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If you have any questions on BMJ Open’s open peer review process please email [email protected] http://bmjopen.bmj.com/ on September 29, 2021 by guest. Protected copyright. BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from

The China Patient-centered Evaluative Assessment of Cardiac Events (China PEACE) Retrospective Heart Failure Study Design

ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2017-020918

Article Type: Protocol

Date Submitted by the Author: 30-Nov-2017

Complete List of Authors: Yu, Yuan; National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease; Chinese Academy of Medical Sciences and Peking Union Medical College Fuwai Hospital Zhang, Hongzhao; National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease; Chinese Academy of Medical Sciences and Peking Union Medical College Fuwai Hospital Li, Xi; National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease; Chinese Academy of Medical Sciences and Peking Union Medical College Fuwai Hospital Lu, Yuan; Yale University School of Medicine Masoudi, Frederick; University of Colorado at Denver - Anschutz Medical

Campus Bookstore http://bmjopen.bmj.com/ Krumholz, Harlan; Yale University School of Medicine; Yale University School of Public Health Li, Jing; Chinese Academy of Medical Sciences and Peking Union Medical College Fuwai Hospital; National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease

Heart failure < CARDIOLOGY, quality of care, outcomes, Cardiac Keywords: Epidemiology < CARDIOLOGY, China on September 29, 2021 by guest. Protected copyright.

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 The China Patent-centered Evaluative Assessment of Cardiac Events (China PEACE) 5 6 Retrospective Heart Failure Study Design 7 8 9 Yuan Yu1, Hongzhao Zhang1, Xi Li1, Yuan Lu2, Frederick A Masoudi3, Harlan M. Krumholz2,4,5, 10 Jing Li1* 11

12 13 Professor Krumholz and Professor Li are joint senior authors. 14 15 Author Affiliations 16 1 National ClinicalFor Research peer Center of Cardiovascular review Diseases, only State Key Laboratory of 17 18 Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, 19 Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's 20 Republic of China; 21 2 Center for Outcomes Research and Evaluation, YaleNew Haven Hospital, and Department 22 of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, United 23 24 States; 25 3 Division of Cardiology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, 26 United States; 27 4 Department of Health Policy and Management, Yale School of Public Health, New Haven, 28 29 Connecticut, United States; 5 30 Section of Cardiovascular Medicine, and the Robert Wood Johnson Clinical Scholars 31 Program the Robert Wood Johnson Clinical Scholars Program, Department of Internal

32 Medicine, Yale University School of Medicine, New Haven, Connecticut, United States. http://bmjopen.bmj.com/ 33

34 35 * Corresponding author: Professor Jing Li 36 National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of 37 Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, 167 38 BeilishiRoad, Beijing 100037, People’s Republic of China; Tel: +86 10 8839 6077; Email: 39 [email protected]

40 on September 29, 2021 by guest. Protected copyright. 41 42 Key words: heart failure, quality of care, outcomes, epidemiology, China 43 44 Word count: 2,823 (main manuscript text excluding title page, abstract, acknowledgments, 45 46 contributor statement, competing interests statement, funding statement, ethical approval 47 statement, transparency statement, data sharing statement, references, figures, and tables) 48 49 50 51 52 53 54 55 56 57 58 59 1 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 Abstract 4 5 Introduction: Heart failure (HF) is a leading cause of hospitalization in China, which is 6 7 experiencing a rapid increase in cardiovascular disease prevalence. Yet, little is known about 8 9 10 current burden of disease, quality of care, and treatment outcomes of heart failure in China. 11 12 Methods and analysis: The China Patientcentered Evaluative Assessment of Cardiac 13 14 Events Retrospective Heart Failure study (China PEACE 5rHF) will examine a nationally 15 16 For peer review only 17 representative sample of more than 10,000 patient records hospitalized for HF in 2015 in 18 19 China. Patients have been selected using a 2stage sampling design stratified by economic– 20 21 22 geographic regions. Data quality will be monitored by a central coordinating center and will 23 24 address case ascertainment, data abstraction, and data management. Analyses will examine 25 26 27 patient characteristics, diagnostic testing, inhospital treatments, inhospital outcomes, costs 28 29 of hospitalization, and hospitallevel variations in these factors. As of October 2017, we have 30 31 sampled 15,438 medical records from 189 hospitals, and have received 15,057 (97.5%) of 32 http://bmjopen.bmj.com/ 33 34 these for data collection, and completed data abstraction and quality control on 7,971. 35 36 37 Ethics and dissemination: The Central Ethics Committee at the Chinese National Center 38 39 for Cardiovascular Diseases approved the study. All collaborating hospitals accepted central

40 on September 29, 2021 by guest. Protected copyright. 41 ethics approval with the exception of 15, which obtained local approval by internal ethics 42 43 44 committees. Findings will be disseminated in future peerreviewed papers and will serve as a 45 46 foundation for improving the care for HF in China. 47 48 49 Trial registration number: NCT02877914. 50 51 52 53 54 55 56 57 58 59 2 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 Strengths and limitations of this study 5 6 A nationally representative sample of hospitals was generated and the study will 7 8 generate the largest reported cohort of patients with HF in China 9 10 11 Medical records were centrally abstracted guided by a standardized data dictionary and 12 13 governed by rigorous data quality standards. 14 15 16 Data collectedFor included peer national disease review burden, patient only characteristics, pattern of care, 17 18 inhospital costs, and shortterm patient outcomes, which will provide pivotal information 19 20 21 for policymakers to improve healthcare quality. 22 23 Data collection is limited to information available in medical records and patient 24 25 outcomes are limited to those occurring during hospitalization. 26 27 28 29 30 31

32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39

40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 3 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 INTRODUCTION 5 6 Heart failure (HF) is a significant public health challenge around the world, including in 7 8 China14, where cardiovascular disease is the leading cause of death.5 Approximately 4.5 9 10 11 million Chinese residents have HF in 2003, and approximately 500,000 incident cases occur 12 13 every year.6 Given China’s aging population and increasing prevalence of cardiovascular 14 15 7,8 16 diseases, the diseaseFor burden peer of HF will risereview rapidly in the coming only years. 17 18 Despite the substantially increasing HF burden in China, little is known about patients 19 20 21 hospitalized for HF. The most recent data on the national epidemiology of HF in China derives 22 23 from a survey performed in 2003.9 While studies from single centers reported the average 24 25 age of patients with HF has increased and comorbidities have shifted markedly during the 26 27 28 past decades,1012 national data on demographic characteristics, precipitating factors, 29 30 comorbidities and echocardiographic characteristics of patients with HF remain unknown. 31

32 http://bmjopen.bmj.com/ 33 Due to their limited scope, existing studies also report different proportions of HF with 34 35 preserved ejection fraction (HFpEF) and with mildly reduced ejection fraction (HFmrEF).1315 36 37 38 Further, while it is widely known that use of guidelinedirected medication is suboptimal in 39 16,17 40 patients with HF and reduced EF (HFrEF), none studies have considered patients’ on September 29, 2021 by guest. Protected copyright. 41 42 43 indications in identifying candidates for therapies, and few have considered contraindications 44 45 to therapy in calculating treatment rates. Furthermore, comparisons in HF care and its 46 47 association with outcomes remain unclear across regions in China with different economic 48 49 50 conditions and medical resources. Globally, substantial regional variations have been 51 52 1821 documented in the presentation, underlying causes, management, and outcomes of HF, 53 54 55 but the disparities in HF care between China and other countries have not been fully 56 57 58 59 4 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 5 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 elucidated due to a lack of standardized definitions for variables in domestic studies which 4 5 6 could be used for crosscountry comparison. Moreover, validated risk models for Chinese 7 8 patients with HF do not currently exist and the national economic burden for HF has not been 9 10 11 accurately estimated. 12 13 To address these knowledge gaps, we use the foundation established by the China 14 15 2224 16 PEACE (PatientcenteredFor peerEvaluative Assessment review of Cardiac only Events) platform, to conduct 17 18 China PEACE 5 Retrospective Study of Patients with Heart Failure (China PEACE 5rHF 19 20 21 study), and generate knowledge from a nationally representative sample of patients 22 23 hospitalized primarily for HF. The specific aims of the study are to (1) estimate the national 24 25 rate and number of hospital admissions for HF; (2) describe the demographic and clinical 26 27 28 characteristics, echocardiographic findings, patterns of inhospital care, and inhospital 29 30 outcomes of patients primarily hospitalized for HF; (3) examine adherence to guideline 31

32 http://bmjopen.bmj.com/ 33 recommendations in HF care, including use of evidencebased medicine and devices, and 34 35 evaluation of left ventricular function; (4) compare treatment patterns across 36 37 38 geographiceconomic regions and hospitals, and determine the association between 39

40 treatment patterns by setting and patient outcomes; (5) compare differences in patient on September 29, 2021 by guest. Protected copyright. 41 42 43 characteristics, treatment approaches, and outcomes between China and other countries; (6) 44 45 develop and test prognostic scores to stratify risk; (7) evaluate national cost of HF inhospital 46 47 care. 48 49 50 This paper describes the study methodology, data collection and abstraction, 51 52 progress to date, and preliminary findings of the China PEACE 5rHF Study. The study 53 54 55 findings will identify opportunities for quality improvement and guide the development of 56 57 58 59 5 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 6 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 strategies and tools to improve outcomes for HF in China. 4 5 6 7 8

9 10 11 METHODS 12 13 Design Overview 14 15 16 The China PEACEFor 5rHF studypeer is a crosssectional review study that only will include a nationally 17 18 representative sample of more than 10,000 patients hospitalizations for HF from January 1st, 19 20 21 2015 to December 31st, 2015 in China, to study patient characteristics, treatment patterns, 22 23 and outcomes nationally and within regions of different socioeconomic development. 24 25 Candidates for inclusion were those with a principal discharge diagnosis of HF, either of 26 27 28 newonset or a decompensation of chronic HF regardless of etiology. Discharge diagnoses 29 30 were identified using International Classification of Diseases Clinical Modification codes 10 31

32 http://bmjopen.bmj.com/ 33 (I50.xx, I11.0x, I13.0x or I13.2x), or through discharge diagnosis terms if ICD10 codes were 34 35 unavailable. 36 37 38 The Central Ethics Committee at the Chinese National Center for Cardiovascular 39

40 Diseases approved the study. All collaborating hospitals accepted central ethics approval on September 29, 2021 by guest. Protected copyright. 41 42 43 with the exception of 15 hospitals, which obtained local approval by internal ethics 44 45 committees. The study is registered at www.clinicaltrials.gov (NCT02877914). 46 47 The Chinese government, which provided financial support for the study in response 48 49 50 to a grant application, had no role in the design or conduct of the study; in the collection, 51 52 management, analysis, and interpretation of the data; or in the preparation or approval of the 53 54 55 article. 56 57 58 59 6 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 7 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3

4 5 6 Sampling Design 7 8 We used a sampling design similar to that used in the China PEACERetrospective 9 10 11 Study of Acute Myocardial Infarction (AMI).22 We generated a nationally representative 12 13 sample of hospitalizations for HF during 2015 using 2stage random sampling. In the first 14 15 16 stage, we identifiedFor study hospitalspeer in 5 strata:review Easternrural, only Centralrural, Westernrural, 17 18 Easternurban, and Central/Westernurban regions to reflect diverse setting of economic 19 20 21 development and healthcare resources in China. The sampling framework of hospitals 22 23 consisted of those with the capacity to provide inhospital care for HF. In each of the rural 24 25 areas (i.e. a county), inhospital care for HF is mainly provided in the central hospital, which is 26 27 28 the largest general hospital with the greatest clinical capacity in the county to treat severe 29 30 acute illness. In the 287 urban areas, inhospital care for HF is mainly undertaken by the 31

32 http://bmjopen.bmj.com/ 33 regionally highestlevel hospitals (usually tertiary hospitals), though both secondary and 34 35 tertiary hospitals have the capacity to provide the care. 36 37 38 We sampled hospitals according to the hospital list in 2010 in China, which included 39

40 5,339 secondary and 1,284 tertiary hospitals. In the 3 rural strata, the sampling framework on September 29, 2021 by guest. Protected copyright. 41 42 43 consisted of the central hospital in each of the predefined rural areas. In the 2 urban strata, 44 45 the sampling framework consisted of both the tertiary and secondary hospitals in each of the 46 47 predefined urban areas, with military hospitals, prison hospitals, specialized hospitals without 48 49 50 a cardiovascular division, and traditional Chinese medicine hospitals excluded. 51 52 In the second stage, we obtained the database of inpatients for HF from each 53 54 55 hospital, and identified cases using a systematic random sampling procedure. In each of the 56 57 58 59 7 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 8 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 5 regional strata, we determined the sample size required to achieve 2% precision for 4 5 6 describing the primary outcome of inhospital death, which was estimated from other studies 7 8 to be 5%.14,25 To achieve a precision of 2% with an α of 0.05 in each of the 2 urban strata, 9 10 11 assuming an interclass correlation of 0.02 and design effect of 2.6, we would need to sample 12 13 2377 medical records among hospitals with an average cluster size of 80. Analogously, to 14 15 16 achieve a precisionFor of 2% peerwith an α of 0.05review in each of the 3 onlyrural strata, assuming an 17 18 interclass correlation of 0.02 and design effect of 2.2, we would need to sample 2011 medical 19 20 21 records among hospitals with an average cluster size of 60. Assuming a participation rate of 22 23 85% among selected hospitals, we approached 35 hospitals for participation in each stratum 24 25 for a total of 175 hospitals (70 urban and 105 rural). We additionally sampled 15 secondary 26 27 28 hospitals to each of the urban strata, to ensure that diverse hospitals providing care for HF 29 30 were included. Consequently, the total expected sample size was 10800 HF patients across 31

32 http://bmjopen.bmj.com/ 33 205 hospitals. 34 35 36 37 38 Data Collection 39

40 We trained site investigators to identify all hospitalizations for HF in 2015 from their on September 29, 2021 by guest. Protected copyright. 41 42 43 respective local hospital databases. After we sampled cases at each hospital, we assigned 44 45 each case a unique study ID. Site investigators scanned complete hospital medical charts of 46 47 all sampled patients, with direct identifiers concealed (name, national ID, and contact 48 49 50 information). All documents of a single patient are collated in one folder with a unique and 51 52 anonymous Participant ID. To facilitate and improve the quality of scanning process, the 53 54 55 coordinating center developed a software to manage the scan, and provided each study site 56 57 58 59 8 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 9 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 with a highspeed scanner. All parts of the medical record were required for scanning, 4 5 6 including the face sheet, admission note, daily progress notes, procedure notes, medication 7 8 administration record, and diagnostic procedure reports including echocardiograms, 9 10 11 laboratory test results, physician orders, nursing notes, and discharge summary. Following 12 13 receipt of each chart, research staff at the coordinating center checked the hospitalization ID 14 15 16 and date of hospitalFor admission peer to verify patientreview identity. The onlydata were evaluated to ensure 17 18 completeness, quality and concealment of direct identifiers. Incomplete or poorly scanned 19 20 21 charts were rescanned. Research staff from the coordinating center visited 20 sites to assist 22 23 in processing the sampled cases. 24 25 We centrally abstracted data from medical records with a standardized data dictionary. 26 27 28 Per the China PEACERetrospective AMI study methodology,22 98% accuracy of medical 29 30 chart abstraction is ensured by rigorous measures. Two contracted vendors abstracted 31

32 http://bmjopen.bmj.com/ 33 details of each patients’ hospitalization using their medical charts. One vendor abstracted the 34 35 part of all medical charts that can be abstracted verbatim without need for interpretation (face 36 37 38 sheet, laboratory test results, and physician orders) via double entry by separate abstractors 39

40 to ensure accuracy. The other vendor abstracted the other part of all medical charts on September 29, 2021 by guest. Protected copyright. 41 42 43 (admission record, discharge record, daily record, and procedure reports). To ensure 44 45 accuracy of their interpretation, these latter data are abstracted by certified abstractors and 46 47 reviewed by senior abstractors. All abstractors received training and were certified. Inner 48 49 50 quality control was conducted by vendors. In addition, research staff at the coordinating 51 52 center checked the vendors’ quality control reports and compared randomly selected records 53 54 55 and abstractions for data accuracy. 56 57 58 59 9 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 10 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3

4 5 6 Data Management 7 8 All data are protected health information and are securely stored in an encrypted 9 10 11 passwordprotected database at the coordinating center. Systematic data cleaning includes 12 13 the identification of potential outliers in the data distribution, and the exclusion of duplicate 14 15 16 records by patientFor and medical peer record identification review numbers. only Suspected errors are reviewed 17 18 and resolved by data managers. 19 20 21 22 23 Data Elements 24 25 To compile a candidate list of potential data elements, we examined relevant literature 26 27 28 from both English and Chinese studies. Chinaspecific elements (e.g. traditional Chinese 29 30 medicines) were included whenever appropriate. We supplemented these elements with 31

32 http://bmjopen.bmj.com/ 33 variables aligned with the American Heart Association Get With The GuidelinesHF 34 35 (GWTGHF) quality improvement program26 and the 2005 ACC/AHA clinical data standards27, 36 37 38 which will permit international comparisons (Table 1). Using these data, we have constructed 39

40 quality indicators that reflect both clinical eligibility as well as documented contraindications to on September 29, 2021 by guest. Protected copyright. 41 42 43 therapies (Table 2). 44 45 46 47 Progress to Date 48 49 50 Among the sampled 205 hospitals, 11 hospitals did not provide inpatient care for HF 51 52 or have no admissions for HF in 2015. By the end of October 2017, we have obtained lists of 53 54 55 patients hospitalized for HF in 2015 from 189 hospitals (Figure 2), which included 171,167 56 57 58 59 10 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 11 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 hospitalizations. Of these, we sampled 15,438 hospitalizations for the China PEACE 5rHF 4 5 6 study, and acquired medical records of 15,057 (97.5%). 7 8

9 10 11 PRELIMINARY RESULTS 12 13 As the project is still in progress, we used data from the first 7,971 medical records, 14 15 16 which have alreadyFor undergone peer abstraction review and data cleaning, only for preliminary analysis. 17 18 Frequencies for categorical variables and medians with interquartile ranges for continuous 19

20 2 21 variables will be calculated. Characteristics are compared between groups by using with χ 22 23 tests for categorical variables and the t tests for continuous variables. A value of P<0.05 was 24 25 be considered statistically significant. All analyses were performed in SAS version 9.3. 26 27 28 The characteristics of these patients are shown in Table 3. The mean age was 71±12 29 30 years, and 49.6% of patients were women. Coronary artery disease and hypertension were 31

32 http://bmjopen.bmj.com/ 33 the most common comorbidities (66.5% and 56.7%, respectively). 58.9% of the patients were 34 35 classified as New York Heart Association function class III or IV. 36 37 38 39

40 DISCUSSION on September 29, 2021 by guest. Protected copyright. 41 42 43 The China PEACE 5rHF study is the first study of HF using rigorous sampling design to 44 45 generate a nationally representative sample of patients and hospitals providing HF care in 46 47 China. This study will generate the largest reported of patients with HF in China and will 48 49 50 characterize the national disease burden, etiology, patient characteristics, pattern of care, 51 52 inhospital costs, and shortterm patient outcomes, which are all fundamental to public health 53 54 55 policymaking and care quality improvement. The China PEACE 5rHF study is based on the 56 57 58 59 11 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 12 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 wellestablished China PEACE research platform, which integrates resources from the 4 5 6 Chinese government, a diverse hospital network, and an international research team to 7 8 translate knowledge of the clinical epidemiology of cardiovascular disease into action for the 9 10 11 benefit of patients. The China PEACE 5rHF study will also take the advantage of China 12 13 PEACE platform significantly elevating the data quality of with techniques regularly employed 14 15 16 by international Forclinical trials peer such as integrated review central and onlyonsite monitoring as well as 17 18 source document verification. This project also elicits the active participation of hospitals 19 20 21 across China to ensure that study results are disseminated broadly for the purpose of quality 22 23 improvement. 24 25 The China PEACE 5rHF study will characterize the current HF burden in China, 26 27 28 supporting national estimates of annual hospitalizations for the first time. HF hospitalizations 29 30 bring a significant strain on healthcare systems and national health expenditures all around 31

32 http://bmjopen.bmj.com/ 33 the world. The resources dedicated to the hospital care of HF hospitalization in China remain 34 35 unclear. This study will have the capacity to estimate costs at the national, regional, hospital, 36 37 38 and patient levels. These results will inform resource allocation to achieve an economical 39

40 equity and efficiency balance. on September 29, 2021 by guest. Protected copyright. 41 42 43 This study will generate evidence to inform contemporary HF medical practice and 44 45 improve outcomes. Investigating quality measures for HF care may reveal gaps between 46 47 current clinical guidelines and practice in the realworld, therefore highlighting the need for 48 49 50 future qualityimprovement efforts to ensure that all patients receiving appropriate treatment. 51 52 We anticipate substantial regional and hospital variation in a broad range of institutions. 53 54 55 These findings will indicate opportunities for improvement that are concentrated in some 56 57 58 59 12 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 13 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 regions, hospitals and patient groups, and identify opportunities to enhance access to 4 5 6 medical resource and equity, and improve the quality and value of care. Geographic 7 8 variations in clinical characteristics and care of patients hospitalized with HF between China 9 10 11 and other countries will have important implications for global clinical trials and outcome 12 13 studies in HF. Risk models derived and validated in domestic patients with HF will help 14 15 16 clinicians guide Forcare and researcherspeer conduct review observational only studies in the future. All these 17 18 findings may influence policy pertinent to HF care in China, as well as offer important lessons 19 20 21 for other low and middleincome countries. 22 23 The China PEACE 5rHF study has some notable strengths in its design. It contains 24 25 the largest and the only representative sample of hospitalizations for HF in China and 26 27 28 therefore includes patients from diverse geographic regions and institutions with widely 29 30 varied capacities. Information will be available on topics that have not been well studied (e.g. 31

32 http://bmjopen.bmj.com/ 33 the use of ICD or CRT in patients with HF). International comparisons will also be possible 34 35 given the alignment of key data elements with the GWTGHF and 2005 ACC/AHA clinical 36 37 38 data standards. Finally, further targeted examination of additional data elements not included 39

40 in the initial case report forms can be performed as novel questions arise, as the NCCD will on September 29, 2021 by guest. Protected copyright. 41 42 43 maintain a physical copy of all charts after the initial abstraction. 44 45 This study is further distinguished by its use of data quality control strategies, which 46 47 are much more common in multinational clinical trials than in large retrospective studies. We 48 49 50 devoted significant attention to data quality at the stages of case ascertainment, data 51 52 abstraction, and data management. For example, research staff rigorously monitored study 53 54 55 sites to identify all hospitalizations for HF from census databases. Staff also ensured that 56 57 58 59 13 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 14 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 medical records for sampled cases were physically found, properly copied, and transmitted in 4 5 6 full whenever possible. In addition, this study provided central training for abstractors and 7 8 required rigorous standards for both initial certification and recertification. Medical records 9 10 11 from abstractors who did not meet recertification requirements were reabstracted by a 12 13 second reviewer. 14 15 16 The ChinaFor PEACE peer5rHF study hasreview some limitations. only First, study findings are 17 18 dependent on the accuracy and completeness of abstracted medical charts. A common 19 20 21 problem caused by this issue is underestimation of comorbidities or complications due to 22 23 missed documentation. However, the record of lab tests, image examinations, medications 24 25 and procedures are very reliable because these records are subjective and linked with 26 27 28 administrative activities, such as fee charge. Moreover, poor documentation of key variables 29 30 will be an important target for quality improvement. Second, HF diagnoses were based on 31

32 http://bmjopen.bmj.com/ 33 medical charts and made by local clinicians, potentially resulting in misclassifications, 34 35 because HF remains a challenging clinical diagnosis. However, the principal discharge 36 37 38 diagnosis of HF has a high positive predictive value compared with other case assessment 39

40 strategies. Finally, our study is also restricted to measuring inhospital outcomes, as we are on September 29, 2021 by guest. Protected copyright. 41 42 43 unable to link patientlevel data to a national registry of death. However, the long lengths of 44 45 stay in Chinese hospitals relative to those in Western countries should permit more robust 46 47 estimates of shortterm complications including death.14,28,29 Moreover, longterm outcomes 48 49 50 and patient experiences will be collected in the recently launched China PEACE 5 51 52 Prospective Study of Patients with Heart Failure. 53 54 55 The China PEACE 5rHF study is the first study on a nationally representative sample 56 57 58 59 14 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 15 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 of Chinese HF patients that assesses the characteristics, inhospital care and outcomes 4 5 6 across patients, hospitals and regions in China. It provides a platform through which 7 8 government, healthcare providers, and research organizations can translate knowledge of 9 10 11 the clinical epidemiology of HF into improved care for patients in the context of increasing 12 13 burden. 14 15 16 For peer review only 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39

40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 15 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 16 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 Figure Legend 5 6 7 8 Figure 1. China PEACE 5rHF study flow chart and associated quality control assurance 9 10 11 strategies. Flow chart should be read from top to bottom. CRF indicates case report form; and 12 13 Q & A, questions and answers. 14 15 16 For peer review only 17 18 Figure 2. Geographic distribution of participating hospitals in the China PEACE 5rHF study. 19 20 21 Of 205 sampled hospitals, 16 were unable or unwilling to participate, and 189 provided cases 22 23 for the China PEACE 5rHF study 24 25

26 27 28 29 30 31

32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39

40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 16 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 17 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 Table 1. China PEACE 5rHF study data elements 5 6 Category Example Elements 7 8 Patient demographics Age, sex, ethnicity, and insurance status 9 10 Myocardial infarction, atrial fibrillation, chronic kidney disease, Medical history 11 diabetes mellitus, and stroke 12 Clinical characteristics at 13 NYHA, heart rate, blood pressure, rales, and edema 14 admission Coronary artery disease, cardiomyopathy, hypertension, valvular 15 Comorbidities 16 For peer heartreview disease, COPD, only anemia, and cancer 17 Arrhythmia, ischemia, respiratory process, Pneumonia, 18 Reasons for exacerbation uncontrolled hypertension, and noncompliancedietary or medicine 19 20 Laboratory values Creatinine, sodium, potassium, hemoglobin, BNP, and troponin 21 Medications Prior to admission, 22 ACEI/ARB, βblocker, aldosterone antagonist, diuretics, digoxin, 23 and during hospitalization anticoagulation, and traditional Chinese medicine 24 (including dose) 25 26 Inhospital procedures ICD, CRT, pacemaker, PCI, and LVAD 27 Echocardiogram(LVEF, size of chambers, pulmonary 28 29 Diagnostic procedure results hypertension, valvular stenosis or regurgitation), chest Xray, and 30 ECG 31 Total expense, death, shock, stroke, bleeding, myocardial Inhospital outcomes 32 infarction, length of stay, and ICU/CCU duration http://bmjopen.bmj.com/ 33 Plans at hospital discharge Medications, diet, weight monitoring, and followup visit 34 35 NYHA indicates New York Heart Association; COPD, chronic obstructive pulmonary disease; 36 37 BNP, brain natriuretic peptide; ACEI, angiotensinconverting enzyme inhibitor; ARB, 38 39 angiotensin receptor blocker; ICD, implantable cardioverter defibrillators; CRT, cardiac

40 on September 29, 2021 by guest. Protected copyright. resynchronization therapy; PCI, percutaneous coronary intervention; LVEF, left ventricular 41 42 ejection fraction; ECG, electrocardiogram, ICU, intensive care unit; CCU, cardiac care unit. 43 44

45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 17 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 18 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 Table 2. China PEACE 5rHF study performance measures* 5 6 In-hospital initiation Therapies at discharge 7 8 ACEI/ARB for HFrEF ACEI/ARB for HFrEF 9 10 βblockers for HFrEF βblockers for HFrEF 11 12 Aldosterone antagonist for HFrEF Aldosterone antagonist for HFrEF 13 14 Anticoagulation for atrial fibrillation Risk intervention 15 16 Evaluation of left ventricular systolic For peer review only 17 function 18 19 CRT therapy in eligible patients 20 21 ICD therapy in eligible patients 22 23 ACEI indicates angiotensinconverting enzyme inhibitor; ARB, angiotensin receptor blocker; 24 HFrEF heart failure with reduced ejection fraction; ICD, implantable cardioverter defibrillators; 25 26 CRT, cardiac resynchronization therapy. 27 28 *Performance measures will be calculated for individuals with clinical indications according to 29 30 ACC/AHA guidelines and without documented contraindications. 31

32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39

26 27 28 Author Contributions 29 30 HMK and JL designed the study and take responsibility for all aspects of it. YY wrote the first 31

32 http://bmjopen.bmj.com/ 33 draft of the article, with further contributions from XL, YL, FAM, HMK and JL. ZZ performed 34 35 statistical analysis. All authors approved the final version of the article. 36 37 38 39

40 Sources of Funding on September 29, 2021 by guest. Protected copyright. 41 42 43 This project was supported by the National Key Technology R&D Program (2015BAI12B02 44 45 and 2015BAI12B01) from the Ministry of Science and Technology of China, CAMS Innovation 46 47 Fund for Medical Sciences (CIFMS 2016I2M2004), and the 111 Project (B16005). 48 49 50 51 52 Conflicts of interest 53 54 55 Dr. Krumholz works under contract with the Centers for Medicare & Medicaid Services to 56 57 58 59 20 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 21 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 develop and maintain performance measures, is chair of a cardiac scientific advisory board 4 5 6 for UnitedHealth, and is the recipient of research grants from Medtronic, Inc. and Johnson & 7 8 Johnson through Yale University. Other coauthors declare no relevant conflicts of interest. 9 10 11 12 13 Ethics approval 14 15 16 The Central EthicsFor Committee peer at the Chinese review National Center only for Cardiovascular Diseases 17 18 approved the study. All collaborating hospitals accepted central ethics approval with the 19 20 21 exception of 15 hospitals, which obtained local approval by internal ethics committees. Trial 22 23 Registration Number: NCT02877914. 24 25

26 27 28 29 30 31

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40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 21 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 22 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 References 4 5 1. Sakata Y, Shimokawa H. Epidemiology of heart failure in Asia. Circulation Journal. 6 7 2013;77(9):22092217. 8 2. Bleumink GS, Knetsch AM, Sturkenboom MC, et al. Quantifying the heart failure epidemic: 9 prevalence, incidence rate, lifetime risk and prognosis of heart failure The Rotterdam Study. 10 European heart journal. 2004;25(18):16141619. 11 3. Sliwa K, Wilkinson D, Hansen C, et al. Spectrum of heart disease and risk factors in a black 12 13 urban population in South Africa (the Heart of Soweto Study): a cohort study. Lancet (London, 14 England). 2008;371(9616):915922. 15 4. Mozaffarian D, Benjamin EJ, Go AS, et al. Heart Disease and Stroke Statistics2016 Update: A 16 Report FromFor the American peer Heart Association. review Circulation. only2016;133(4):e38360. 17 18 5. He J, Gu D, Wu X, et al. Major causes of death among men and women in China. The New 19 England journal of medicine. 2005;353(11):11241134. 20 6. Hu SS, Kong LZ, editors. Report on cardiovascular diseases in China 2009. National Centre of 21 Cardiovascular diseases Encyclopedia of China Publishing House; 2009. 22 7. Ministry of Health of People's Republic of China. China Public Health Statistical Yearbook 23 24 2016. Beijing: Peking Union Medical College Publishing House; 2016. 25 8. Zeng Y, Wang Z. A Policy Analysis on Challenges and Opportunities of Population/Household 26 Aging in China. Journal of Population Ageing. 2014;7(4):255281. 27 9. Gu DF, Huang GY, Wu XG, et al. Investigation of prevalence and distributing feature of chronic 28 29 heart failure in Chinese adult population. Zhonghua xin xue guan bing za zhi. 2003(01):69. 30 10. Pei ZY, Zhao YS, Li JY, Xue Q, Gao L, Wang SW. Fifteenyear evolving trends of etiology and 31 prognosis in hospitalized patients with heart failure. Zhonghua xin xue guan bing za zhi.

32 2011;39(5):434439. http://bmjopen.bmj.com/ 33 11. Yin Q, Zhao Y, Hou X, Miu J. Longterm trends of inhospital mortality in patients with heart 34 35 failure: from 1993 to 2007. Chinese Journal of Cardiovascular Medicine. 2012(04):276279. 36 12. Liu J, Ma JP, Huang JH, Wang L. A study of the influence of the guideline on the treatment of 37 chronic congestive heart failure in the elderly. Zhongguo wei zhong bing ji jiu yi xue. 38 2010;22(10):606609. 39 13. Zhou HB, An DQ, Zhan Q, et al. A retrospective analysis of clinical characteristics and

40 on September 29, 2021 by guest. Protected copyright. 41 outcomes of heart failure patients with different left ventricular ejection fractions. Zhonghua nei 42 ke za zhi. 2017;56(4):253257. 43 14. Zhang J, Zhang YH. China Heart Failure Registry Study——A Multicenter, Prospective 44 Investigation for Preliminary Analysis on Etiology, Clinical Features and Treatment in Heart 45 46 Failure Patients. Zhongguo Xun Huan Za Zhi. 2015(05):413416. 47 15. Liu DP, Wang F, Zeng XZ, Zhang XC. Clinical characteristics and prognosis of heart failure 48 with normal left ventricular ejection fraction in elderly patients. Chinese medical journal. 49 2012;125(16):28532857. 50 51 16. Fu R, Xiang J, Bao H, et al. Association between process indicators and inhospital mortality 52 among patients with chronic heart failure in China. European journal of public health. 53 2015;25(3):373378. 54 17. He XY, Bundorf MK, Gu JJ, Zhou P, Xue D. Compliance with clinical pathways for inpatient 55 care in Chinese public hospitals. BMC health services research. 2015;15:459. 56 57 58 59 22 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 23 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 18. West R, Liang L, Fonarow GC, et al. Characterization of heart failure patients with preserved 4 ejection fraction: a comparison between ADHEREUS registry and ADHEREInternational 5 registry. European journal of heart failure. 2011;13(9):945952. 6 7 19. Lam CS, Teng TK, Tay WT, et al. Regional and ethnic differences among patients with heart 8 failure in Asia: the Asian sudden cardiac death in heart failure registry. European heart journal. 9 2016. 10 20. Callender T, Woodward M, Roth G, et al. Heart failure care in low and middleincome 11 countries: a systematic review and metaanalysis. PLoS medicine. 2014;11(8):e1001699. 12 13 21. Dokainish H, Teo K, Zhu J, et al. Global mortality variations in patients with heart failure: 14 results from the International Congestive Heart Failure (INTERCHF) prospective cohort study. 15 The Lancet. Global health. 2017. 16 22. DharmarajanFor K, Li peer J, Li X, Lin Z,review Krumholz HM, Jiang only L. The China PatientCentered 17 18 Evaluative Assessment of Cardiac Events (China PEACE) Retrospective Study of Acute 19 Myocardial Infarction: Study Design. Circ Cardiovasc Qual Outcomes. 2013;6(6):732740. 20 23. Li J, Li X, Wang Q, et al. STsegment elevation myocardial infarction in China from 2001 to 21 2011 (the China PEACERetrospective Acute Myocardial Infarction Study): a retrospective 22 analysis of hospital data. Lancet (London, England). 2015;385(9966):441451. 23 24 24. Kirtane AJ, Stone GW. STEMI care in China: a world opportunity. Lancet (London, England). 25 2015;385(9966):400401. 26 25. Yin Q, Zhao Y, Li J, et al. The coexistence of multiple cardiovascular diseases is an 27 independent predictor of the 30day mortality of hospitalized patients with congestive heart 28 29 failure: a study in Beijing. Clinical cardiology. 2011;34(7):442446. 30 26. Get With The Guidelines@ Heart failure. 31 http://www.heart.org/HEARTORG/Professional/GetWithTheGuidelines/GetWithTheGuidelines

32 HF/GetWithTheGuidelinesHeartFailureHomePage_UCM_306087_SubHomePage.jsp. http://bmjopen.bmj.com/ 33 Accessed 1/9, 2015. 34 35 27. Radford MJ, Arnold JM, Bennett SJ, et al. ACC/AHA key data elements and definitions for 36 measuring the clinical management and outcomes of patients with chronic heart failure: a 37 report of the American College of Cardiology/American Heart Association Task Force on 38 Clinical Data Standards (Writing Committee to Develop Heart Failure Clinical Data Standards): 39 developed in collaboration with the American College of Chest Physicians and the

40 on September 29, 2021 by guest. Protected copyright. 41 International Society for Heart and Lung Transplantation: endorsed by the Heart Failure 42 Society of America. Circulation. 2005;112(12):18881916. 43 28. Kapoor JR, Kapoor R, Ju C, et al. Precipitating Clinical Factors, Heart Failure Characterization, 44 and Outcomes in Patients Hospitalized With Heart Failure With Reduced, Borderline, and 45 46 Preserved Ejection Fraction. JACC. Heart failure. 2016;4(6):464472. 47 29. Filippatos G, Farmakis D, Bistola V, et al. Temporal trends in epidemiology, clinical 48 presentation and management of acute heart failure: results from the Greek cohorts of the 49 Acute Heart Failure Global Registry of Standard Treatment and the European Society of 50 51 CardiologyHeart Failure pilot survey. European heart journal. Acute cardiovascular care. 52 2014. 53 54 55 56 57 58 59 23 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 24 of 108 Flow Chart of sampling, data collection, cleaning and analysis BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from

1 Collaborating Hospitals Coordinating Center Abstractors 2 3 4 Hospital sampling 5 6 7 Invite sampled hospitals to 8 participate 9 10 Identify eligible hospitalizations 11 Train participating hospitals 12 • Standardized search strategy 13 14 15 16 For peerConfirm searchreview strategy only 17 18 Incorrect 19 20 Correct 21 22 Drop untargeted cases 23 24 25 Find charts of sampled cases Case sampling 26 27 28 29 Scan charts Confirm 30 • Installed application in local completeness and 31 computers scan quality of • Provided high-speed scanner 32 charts http://bmjopen.bmj.com/ 33 Unacceptable 34 35 Acceptable Abstraction • Intensive training 36 • Comprehensive data dictionary 37 Rename images of charts • Test for qualification 38 • Electronic CRF 39 • On-line Q & A • Abstractions by medical 40 professionals as needed on September 29, 2021 by guest. Protected copyright. 41 42 43 Central quality control • Check IQC report Inner quality control (IQC) 44 • Check sampled data 45 46 Unqualified 47 48 Qualified 49 50 Data cleaning 51 • Regular cleaning 52 • Potential errors traced to 53 original charts 54 55 Analysis 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 25 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 For peer review only 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

32 http://bmjopen.bmj.com/ 33 Figure 2. Geographic distribution of participating hospitals in the China PEACE 5r-HF study. Of 205 sampled 34 hospitals, 16 were unable or unwilling to participate, and 189 provided cases for the China PEACE 5r-HF study. 35 36 352x282mm (72 x 72 DPI) 37 38 39

40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 26 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 SUPPLEMENTAL MATERIAL 4 5 Title: The China Patentcentered Evaluative Assessment of Cardiac Events (China PEACE) 6 Retrospective Heart Failure Study Design 7 1 1 1 2 3 2,4,5 8 Yuan Yu , Hongzhao Zhang , Xi Li , Yuan Lu , Frederick A Masoudi , Harlan M. Krumholz , 1* 9 Jing Li 10 11 12 Author Affiliations 1 13 National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of 14 Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, 15 Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's 16 Republic of China; 2 For peer review only 17 Center for Outcomes Research and Evaluation, YaleNew Haven Hospital, and Department 18 of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, United 19 States; 3 20 Division of Cardiology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, 21 United States; 4 22 Department of Health Policy and Management, Yale School of Public Health, New Haven, 23 Connecticut, United States; 5 24 Section of Cardiovascular Medicine, and the Robert Wood Johnson Clinical Scholars 25 Program the Robert Wood Johnson Clinical Scholars Program, Department of Internal 26 Medicine, Yale University School of Medicine, New Haven, Connecticut, United States. 27 28 * Corresponding author: Professor Jing Li 29 National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of 30 Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, 167 31 BeilishiRoad, Beijing 100037, People’s Republic of China; Tel: +86 10 8839 6077; Email: [email protected] 32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39

32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39

40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 2 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 28 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 STUDY SAMPLING DESIGN 4 5 We intended study hospitals to reflect diverse sites of care in China. As hospital volumes and 6 clinical capacities differ between urban and rural areas as well among the 3 official 7 economicgeographic regions of China, we separately identified hospitals in 5 strata: 8 Easternrural, Centralrural, Westernrural, Easternurban, and Central/Westernurban 9 regions. We considered an area urban if it is part of a downtown or suburban area within a 10 directcontrolled municipality (Beijing, Tianjin, Shanghai, Chongqing) or 1 of 283 11 prefecturallevel cities. We considered surrounding countylevel regions, including counties 12 and countylevel cities, to be rural. Within this framework, China is composed of 287 urban 13 regions and 2010 rural regions. We considered Central and Western urban regions together 14 given their similar per capita income and health services capacity as shown below: 15 16 For peer review only 17 Population, Economy, and Hospitals in Different Geographic Strata of Mainland China 18 Eastern Central Western 19 Rural Setting 20 Population* 256,899,053 205,567,264 222,491,738 21 Income per capita (RMB)† 9,256 6,351 5,604 22 23 Level of central hospital 24 Tertiary (%) 33 (5%) 12 (2%) 30 (3%) 25 Secondary (%) 586 (92%) 462 (92%) 739 (85%) 26 Primary (%) 20 (3%) 26 (5%) 102 (12%) 27 Total 639 500 871 28 29 Urban Setting 30 Population* 336,364,491 150,467,917 144,803,916 31 Income per capita (RMB) † 21,547 15,539 15,523

32 Median of hospitals per urban area http://bmjopen.bmj.com/ 33 (IQR)‡ 34 Tertiary 3.2±0.3 2.3±0.3 2.3±0.3 35 Secondary 5.1±0.6 3.0±0.3 3.0±0.4 36 37 * Statistics in 2009 from the National Bureau of Statistics of China (http://www.stats.gov.cn/tjsj/ndsj/2010/indexch.htm) 38 † Statistics (RMB) in 2009 from the National Bureau of Statistics of China 39 (http://www.stats.gov.cn/tjsj/ndsj/2010/indexch.htm)

40 on September 29, 2021 by guest. Protected copyright. ‡ Mean ± S.E. 41

42 43 44 We identified cases for study inclusion using a stratified 2stage cluster sampling design. In 45 the first stage, we identified hospitals using a simple random sampling procedure within each 46 of the 5 study strata. In the second stage, we drew cases based on the local hospital 47 database for patients with HF at each sampled hospital. 48 Typically, secondary and tertiary hospitals have capacity to provide care for patients 49 hospitalized for heart failure (HF) in China (level of hospital is officially defined by the Chinese 50 government based on clinical resource capacity). In each rural region, inhospital cares for 51 HF are mainly provided by the central hospitals, which mostly are secondary ones. In urban 52 regions, inhospital cares for HF are mainly undertaken by the local highestlevel hospitals, 53 though both secondary and tertiary ones are capable to provide the care. We excluded 54 military hospitals, prison hospitals, specialized hospitals without a cardiovascular disease 55 division, and traditional Chinese medicine hospitals. We sampled hospitals according to the 56 2010 hospital list. Increases in the number of hospitals from 2010 until now has no effect on 57 58 59 3 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 29 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 representativeness of our sample, because there remains only one central hospital in each 4 county. Although 54 new urban hospitals founded during 2011 to 2015 may influence the 5 representativeness, the effect was very limited, for they only accounting for 6% of the eligible 6 highestlevel hospitals in urban regions. 7 8 In each of the 3 rural strata, 35 hospitals were randomly from the sampling framework that 9 consisted of the central hospital in each of the predefined rural regions (2010 central 10 hospitals in 2010 rural regions); in each of the 2 urban strata, 35 hospitals were sampled 11 randomly from the primary sampling framework that consisted of highestlevel hospitals in 12 each of the predefined urban regions (833 hospitals in 287 urban regions), then 15 additional 13 secondary hospitals were sampled as a supplementary group. 14 15 In the second stage, we drew cases based on the local hospital database for patients with HF 16 at each sampled hospital. We ordered each hospital’s list of eligible cases by date of admission and selectedFor cases peer using systematic review random sampling only with equal probabilities. 17 th 18 We selected a case at random, after which we selected every k case based on sample size 19 requirements, where k is the sampling interval. 20 21 In each of the 5 study strata, we determined the sample size required to achieve a 2% 22 precision for describing the primary outcome, inhospital mortality, which we had estimated to 23 be approximately 5%. 24 25 The following Equation 1 can be used to define the sample size (n) required for a given 26 proportion of the primary outcome (P), desired precision (d), and specific choice of α. 27 28 29 Equation 1: ∙ 1 − 30 = ∝ 31

32 http://bmjopen.bmj.com/ 33 34 However, because random cases sampled within the same hospital are likely to be more 35 similar to one another than to random cases from another hospital, the effective sample size 36 is reduced. Consequently, a design effect adjustment should be introduced as follows: 37 38 39 Equation 2:

40 ∙ 1 − on September 29, 2021 by guest. Protected copyright. = ∝ × 41 42 43 44 Where the design effect (deff) is given by 45 46 47 Equation 3: 48 = 1 + ′ − 1 49

51 52 where is the intraclass correlation for the statistic in question and ′ is the average 53 number of sampled cases within each hospital. ′ is also known as the cluster size. 54 55 With this framework in mind, assuming an intraclass correlation of 0.02 and design effect of 56 2.2, to achieve a precision of 2% with an α of 0.05 in each of the 3 rural strata, we need to 57 58 59 4 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 30 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 sample 2011 medical records among hospitals with an average cluster size of 60. 4 Analogously, assuming an intraclass correlation of 0.02 and design effect of 2.6, to achieve a 5 precision of 2% with an α of 0.05 in each of the 2 urban strata, we would need to sample 2377 6 medical records among hospitals with an average cluster size of 80. Assuming an anticipated 7 participation rate of 85% among selected hospitals, we approached 35 hospitals for 8 participation in each stratum. We further sample urban secondary hospitals to improve the 9 study’s descriptive accuracy of hospitals with different levels and conditions in urban strata. In 10 each urban strata, we randomly sample 15 secondary hospitals from the remaining 11 secondary hospitals. 12 13 Consequently, the total expected sample volume with the above assumptions is 14 approximately 10800 from 205 hospitals (100 urban and 105 rural). 15 16 For peer review only 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39

40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 5 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 31 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 QUALITY ASSURANCE AND QUALITY CONTROL STRATEGIES IN MEDICAL RECORD 4 SAMPLING 5 6 Since the China PEACE 5rHF study was designed to study a nationally representative 7 hospital cohort, we selected hospitals based on random sampling rather than previous 8 collaboration or longstanding experience with retrospective data collection. As we anticipated 9 that many hospitals would have little previous experience with clinical research, we provided 10 participating sites with substantial support to ensure adherence with multiple quality control 11 strategies for identifying the universe of hospitalizations for heart failure (HF). 12 13 For all participating hospitals, we first held a local investigator meeting to provide indepth 14 information on study design and operating procedures. We trained sites on how to identify 15 their universe of hospitalizations for HF. We specified 3 possible approaches. Our first 16 preference was Forthat sites querypeer their electronic review database of onlyhospitalizations for patients 17 discharged with a discharge diagnosis of HF. ICD10 codes I50, I11.0, I13.0 or I13.2 were 18 used when every discharge diagnosis was coded, and all possible key terms “heart failure”, 19 “heart disfunction” or “NYHA IIIV” were used if only part of discharge diagnosis was coded in 20 the database. We exclude records from departments can’t treat HF, for example, surgery. If 21 such a database was not available, we required that site coordinators manually search the 22 written hospitalization log in the hospital archiving office for hospitalizations for HF. Site 23 coordinators reviewed the original medical record in cases where the diagnosis of HF was 24 uncertain. Finally, as the least preferred option, we asked that study coordinators manually 25 search the written log of hospitalizations of each hospital ward for cases for HF. Site 26 coordinators reviewed the original medical records in cases of uncertain diagnosis. 27 28 After we drew case samples at each hospital using systematic random sampling and 29 assigned each record a unique study ID, we required local investigators to gather the original 30 record, assign it its study ID, scan it, and transmit the scanned copy to the coordinating center. 31 Upon receipt of the scanned record, assessors verified the accuracy of the study ID and ensured that the record itself was complete and legible, and renamed the images according

32 http://bmjopen.bmj.com/ their original part of medical records, such as front page, order, ECG, etc. To facilitate this 33 process, the coordinating center provided each study site with a highspeed scanner. 34

35 To ensure transparency in all sampling performed by the NCCD, we have recorded all 36 sampling procedures including the contents of the sampling framework database that 37 contains all eligible cases for sampling in their predefined sequence and the seeds used in 38 random number generation. 39

40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 6 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 32 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 QUALITY ASSURANCE AND QUALITY CONTROL STRATEGIES IN MEDICAL RECORD 4 ABSTRACTION 5 6 Background 7 8 Medical record abstraction can be guided by the types of data being abstracted. We have 9 defined hard data elements as those elements that can be abstracted directly from the chart 10 without use of professional judgment. Examples include the date of admission, patient sex, 11 patient age, serum BNP, etc. Based on the results of a pilot study of 500 medical records, we 12 required that a data element be abstracted with greater than 98% accuracy to be considered 13 hard. The quality of abstraction of hard data elements depends primarily on the 14 conscientiousness of abstractors as well as the legibility of the records themselves. 15 16 In contrast, soft Fordata elements peer are those review that require more advancedonly medical knowledge for 17 abstraction. Examples of soft data elements include the presence of comorbidities, evidence 18 of rale on hospital presentation, inhospital complications such as bleeding or stroke, and so 19 on. 20 21 Within the Chinese medical record, hard data elements are found predominantly in the front 22 page, and the section for laboratory testing results and physician orders. Soft elements are 23 found throughout all other sections of the medical record including the admission record, 24 discharge record, diagnostic reports, etc. 25 26 Training and Qualification of Abstractors 27 28 China PEACE has made use of abstractors with and without formal medical training. 29 Abstractors without formal medical training were hired from companies with experience in 30 medical data entry and/or medical record abstraction. Abstractors with medical training 31 included both undergraduate and postgraduate students from medical school.

32 http://bmjopen.bmj.com/ Each abstractor was given a set of training materials about medical record abstraction, 33 including CHINA PEACE 5rHF: A Brief Introduction, China PEACE 5rHF: Operation Manual 34 of Medical Record Abstraction, and 5 standard training medical records. 35

36 Each abstractor also underwent the following training courses: (1) Introduction to the study 37 protocol; (2) Component parts of the inpatient medical record and their contents; (3) China 38 PEACE 5rHF data dictionary; (4) Frequently asked questions in medical record abstraction; 39 (5) Quality assurance and quality control measures in China PEACE5rHF; and (6) Intensive

40 on September 29, 2021 by guest. Protected copyright. guidance in abstracting 5 standard training medical records followed by group discussion and 41 retraining as needed. 42

43 Once training was completed, each abstractor reviewed 5 standard training medical records. 44 Supervisors were responsible for evaluating the integrity of abstraction. For qualification, 45 accuracy of abstraction had to be greater than 98 percent, including for soft data elements. 46 Failure to meet this standard resulted in additional training as required. 47 48 Quality Control in Medical Record Abstraction 49 50 We assigned the front page, laboratory results, echocardiography reports and physician 51 orders sections of the medical records to qualified nonmedical abstractors, as these sections 52 contain almost exclusively hard data elements. We performed a second abstraction of all 53 records abstracted by nonmedical abstractors to ensure accuracy. 54 55 Abstractors with formal medical training abstracted all sections of the medical chart 56 containing soft data elements. These include the admission note, daily progress notes, 57 58 59 7 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 33 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 procedure notes, diagnostic testing reports, medication administration record, nursing notes, 4 and discharge summary. There is inner quality control (IQC) by vendors. We routinely check 5 the IQC report, as well as randomly audited 510 abstracted records for each batch. If the 6 IQC reports were not qualified or audited records were not abstracted with 98% accuracy, all 7 medical records in the audited batch were considered unqualified and were rereviewed by a 8 different abstractor. Discrepancies in abstraction were resolved by review of the original 9 medical record. 10 11 To minimize abstraction errors, a physician was always available online to answer questions 12 and address areas of concern as they arise. Common problems have led to updates of the 13 data dictionary and computer program into which data were directly entered. Furthermore, 14 medical records belonging to the same hospital were assigned to a broad group of reviewers 15 to avoid potential residual disparities in quality among different abstractors 16 For peer review only 17 Data Management and Cleaning 18 19 Ongoing data cleaning is performed in a systematic manner. Data is regularly queried for 20 invalid and illogical values as well as for duplicate record entry. Invalid values are identified as 21 outliers in continuous data distributions. Duplicate records are identified by the presence of 22 similar study identification numbers, hospital identification numbers, medical record 23 identification numbers, and the date of discharge. Once a potential error is found, the issue is 24 resolved after tracing and reviewing the relevant records. 25 26 Frequent sources of error result in additional intensive training for abstractors and 27 supervisors, if necessary. The study’s data dictionary is updated as needed. 28 29 30 31

32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39

40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 8 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 34 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 CASE REPORT FORM 4 5 Patient ID: 6 Medical record number: 7 8 ARRIVAL AND ADMISSION INFORMATION 9 Admit Date and Time: ______/______/______: ______10 MM/DD/YYYY only 11 Unknown/Date UTD 12 Department of Admission: 13 Cardiovascular Department CCU/ICU 14 Internal Medicine Department Other 15 Geriatrics Unrecorded 16 Cadre’s Ward For peer review only 17 18 DEMOGRAPHIC DATA 19 Age: ______20 Date of Birth: ______/______/______21 Gender: Male Female Unknown 22 Ethnicity: 23 Han Hui Tujia Other 24 Zhuang Miao Yi Unrecorded 25 Man Weiwuer Buyi 26 Medical Insurance: 27 Urban Employeebased Basic Medical Insurance (UEBMI) 28 Urban Residentbased Basic Medical Insurance (URBMI) 29 Rural New Cooperative Medical scheme (NCMS) 30 Payment OutofPocket 31 Free Medical Care

32 Urbanrural Residentbased Basic Medical Insurance  http://bmjopen.bmj.com/ 33 Other insurance 34 Unrecorded 35 36 DIAGNOSIS 37 Admission diagnosis (Select all that apply) 38 Cardiac related: 39 ☐Heart failure

40 NYHA class I II III IV Not Available on September 29, 2021 by guest. Protected copyright. 41 ☐Coronary artery disease 42 ☐Acute myocardial infarction 43 ☐Prior PCI 44 ☐Unstable angina 45 ☐Prior MI 46 ☐Prior CABG 47 ☐Valvular heart disease 48 ☐Congenital cardiac disease 49 ☐Hypertension 50 ☐Atrial fibrillation (chronic or recurrent) 51 ☐CRTD (cardiac resynchronization therapy with ICD) 52 ☐CRTP (cardiac resynchronization therapypacing only) 53 ☐Pacemaker 54 ☐ICD only 55 ☐Cardiomyopathy 56 ☐Cardiogenic shock 57 58 59 9 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 35 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 ☐Prior Cardiac valve surgeon 4 ☐Prior heart transplant 5 ☐Myocarditis 6 ☐Alcoholic cardiomyopathy 7 ☐Pulmonary hypertension 8 Noncardiac related: 9 ☐Dyslipidemia 10 ☐Diabetes mellitus 11 ☐Type 2 Diabetes mellitus 12 ☐Prior cerebrovascular ischemic stroke 13 ☐Prior cerebrovascular hemorrhagic stroke 14 ☐Prior unspecific stroke 15 ☐Acute cerebrovascular ischemic stroke 16 ☐Acute cerebrovascularFor hemorrhagicpeer stroke review only 17 ☐Acute unspecific stroke 18 ☐Cancer 19 ☐Anemia 20 ☐COPD 21 ☐Peripheral vascular disease 22 ☐Chronic renal disease 23 ☐Liver cirrhosis 24 ☐Asthma 25 ☐Pregnancy 26 ☐Bleeding 27 ☐Peptic ulcer 28 ☐Systemic lupus erythematosus 29 ☐DVT or PE (pulmonary embolus) 30 ☐Bilateral renal artery stenosis 31 ☐Moderatesevere aortic stenosis ☐Pneumonia 32 http://bmjopen.bmj.com/ 33 Discharge diagnosis (Select all that apply) 34 Cardiac related: ☐ 35 Heart failure 36 NYHA class I II III IV Not Available ☐ 37 Coronary artery disease ☐ 38 Acute myocardial infarction ☐ 39 Prior PCI ☐Unstable angina

40 on September 29, 2021 by guest. Protected copyright. ☐ 41 Prior MI ☐ 42 Prior CABG ☐ 43 Valvular heart disease ☐ 44 Congenital cardiac disease ☐ 45 Hypertension ☐Atrial fibrillation (chronic or recurrent) 46 ☐CRTD (cardiac resynchronization therapy with ICD) 47 ☐CRTP (cardiac resynchronization therapypacing only) 48 ☐Pacemaker 49 ☐ICD only 50 ☐Cardiomyopathy 51 ☐Cardiogenic shock 52 ☐Prior Cardiac valve surgeon 53 ☐Prior heart transplant 54 ☐Myocarditis 55 ☐Alcoholic cardiomyopathy 56 57 58 59 10 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 36 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 ☐Pulmonary hypertension 4 Noncardiac related: 5 ☐Hyperlipidemia 6 ☐Diabetes mellitus 7 ☐Type 2 Diabetes mellitus 8 ☐Prior cerebrovascular ischemic stroke 9 ☐Prior cerebrovascular hemorrhagic stroke 10 ☐Prior unspecific stroke 11 ☐Acute cerebrovascular ischemic stroke 12 ☐Acute cerebrovascular hemorrhagic stroke 13 ☐Acute unspecific stroke 14 ☐Cancer 15 ☐Anemia 16 ☐COPD For peer review only 17 ☐Peripheral vascular disease 18 ☐Chronic renal disease 19 ☐Liver cirrhosis 20 ☐Asthma 21 ☐Pregnancy 22 ☐Bleeding 23 ☐Peptic ulcer 24 ☐Systemic lupus erythematosus 25 ☐DVT or PE (pulmonary embolus) 26 ☐Bilateral renal artery stenosis 27 ☐Moderatesevere aortic stenosis 28 29 Medical History 30 Medical History (Select all that apply) 31 ☐None ☐Diabetesnoninsulin treated ☐Atrial flutter (chronic or recurrent) ☐Heart failure 32 http://bmjopen.bmj.com/ ☐ ☐ 33 Atrial fibrillation (chronic or recurrent) ICD only ☐ ☐ 34 CRTD (cardiac resynchronization therapy Prior CABG ☐ 35 with ICD) Renal insufficiencychronic (SCr >2.0) ☐ ☐ 36 CRTP (cardiac resynchronization COPD or asthma ☐ 37 therapypacing only) Cerebrovascular ischemic stroke ☐ ☐ 38 Dialysis (chronic) Cerebrovascular hemorrhagic stroke ☐ ☐ 39 Hypertension Unspecific stroke ☐Peripheral vascular disease ☐Dyslipidemia

40 on September 29, 2021 by guest. Protected copyright. ☐ ☐ 41 Prior PCI Pacemaker ☐ ☐ 42 Ventricular assist device Valvular heart disease ☐ ☐ 43 Anemia Congenital cardiac disease ☐ ☐ 44 Coronary artery disease Cancer ☐ ☐ 45 Prior MI Liver cirrhosis ☐Diabetes mellitus 46 ☐Diabetesinsulin treated 47 History of Cigarette Smoking? 48 Never Smoking 49 Current smoker 50 Past smoker 51 Unrecorded 52 Smoking Frequency: ______Cigarettes/Day 53 Heart Failure (HF) History 54 Etiology (Check if history of) 55 Ischemic/CAD 56 Cardiomyopathy 57 58 59 11 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 37 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 Constructive (Pricardial diseases or Valvular heart disease or Congenital heart disease) 4 Myocarditis 5 Hypertensive 6 Alcohol or drug abuse 7 Chemotherapy or Chest radiotherapy 8 Arrhythmic 9 Unknown/Idiopathic 10 Other etiology 11 Hospital admission in past 6 mo. for HF: 0 1 2 >2 Unknown 12 13 CONDITIONS CONTRIBUTING TO HF EXACERBATION (Select all that apply) 14 ☐Arrhythmia ☐Worsening renal failure 15 ☐Ischemia/ACS ☐Noncompliancedietary 16 ☐Pneumonia/respiratoryFor processpeer review☐Noncompliancemedication only 17 ☐Uncontrolled HTN ☐Other 18 19 MEDICATION Prior to ADMISSION 20 ☐Patient on no meds prior to admission ☐No meds listed 21 ☐ACE inhibitor ☐Angiotensin receptor blocker (ARB) 22 ☐Aldosterone antagonist ☐Antiarrhythmic 23 ☐ ☐ 24 Antiplatelet agent (excluding aspirin) Digoxin 25 ☐Aspirin ☐Nitrate 26 ☐Beta blocker ☐Hydralazine 27 ☐Ca channel blocker ☐Omega3 fatty acid supplement 28 ☐Diabetic Medications (Any) ☐Renin Inhibitor 29 ☐Anticoagulation Therapy: 30 Warfarin Direct Thrombin Inhibitor Factor Xa Inhibitor Other 31 ☐Diuretic: 32 Thiazide/Thiazidelike Loop http://bmjopen.bmj.com/ 33 ☐Lipid lowering agent (Any): 34 Statin Other lipid lowering agent 35 ☐Other 36 37 EXAM/LABS AT ADMISSION 38 Symptoms (closest to admission, check all that apply) 39 ☐Chest pain ☐Palpitation

40 on September 29, 2021 by guest. Protected copyright. 41 ☐Dyspnea at rest ☐Fatigue 42 ☐Orthopnea ☐Decreased appetite/early satiety 43 ☐Dyspnea on exertion ☐Dizziness/lightheadedness/syncope 44 ☐Paroxysmal nocturnal dyspnea 45 Vital Signs (closest to admission) 46 Height ______cm Not documented 47 Weight ______kg Not documented 48 Heart Rate ______bpm ND 49 BP ______/______mmHg (systolic/diastolic) ND 50 Respiratory rate ______breaths per minute 51 Exam (closest to admission) 52 The third heart sound Yes No Unknown 53 Jugular venous distension Yes No Unknown 54 Hepatojugular reflux Yes No Unknown 55 Rales Yes No Unknown If yes, <1/3 ≥1/3 N/A 56 Lower extremity edema Yes No Unknown 57 58 59 12 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 38 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 Lipids 4 TC_____ mg/dL HDL_____ mg/dL LDL_____ mg/dL TG_____ mg/dL 5 Lipids Not Available 6 Labs (closest to admission) 7 Na ______mEq/L Not Available 8 Hgb ______g/L Not Available 9 Albumin ______g/dL g/L Not Available 10 BNP ______pg/mL Not Available 11 NBNP ______pg/mL Not Available 12 SCr ______mg/dL Not Available 13 BUN ______mg/dL Not Available 14 Troponin (Peak) ______ng/dL Not Available 15 T I Normal Abnormal 16 Troponin ULN ______For peer ng/dL review only 17 K ______mEq/L Not Available 18 HbA1C ______% Not Available 19 Fasting Blood Glucose ______mg/dL Not Available 20 Chest Xray: Pulmonary edema Pulmonary congestion Bilateral pleural 21 effusion Cardiomegaly Not Available 22 23 INHOSPITAL CARE 24 Exams 25 EKG QRS Duration ______ms Not Available 26 EKG QRS Morphology: Normal LBBB RBBB NSIVCD Paced Not Available 27 Cardiac magnetic resonance imaging Yes No Not Available 28 Cardiac computerized axial tomography Yes No Not Available 29 Coronary computerized axial tomography Yes No Not Available 30 Heart biopsy Yes No Not Available 31 Cardiac positron emission tomography Yes No Not Available Stress testing Yes No Not Available

32 http://bmjopen.bmj.com/ 6minute walk test Yes No Not Available If yes, ______m 33 Continuous ambulatory ECG monitoring for HF Yes No Not Available 34 Radionuclide ventriculography Yes No Not Available 35 Procedures 36 ☐ ☐ 37 No procedures PCI 38 ☐Cardiac Cath/Coronary angiography ☐Atrial fibrillation ablation or surgery 39 ☐Cardioversion ☐Cardiac valve surgery

40 ☐Dialysis/ Ultrafiltration ☐Coronary artery bypass graft on September 29, 2021 by guest. Protected copyright. 41 ☐Intraaortic balloon pump ☐Mechanical ventilation 42 ☐Left ventricular assist device ☐Right cardiac catheterization 43 ☐Pacemaker ☐Transplant (heart) 44 ☐CRTD (cardiac resynchronization therapy with ICD) 45 ☐CRTP (cardiac resynchronization therapypacing only) 46 47 EFQuantitative ______% EFQualitative 48 Normal or mild dysfunction 49 Qualitative moderate/severe dysfunction 50 Not performed 51 Documented LVSD Yes No 52 LVF assessment Yes No 53 Blood transfusion during hospitalization: Yes No/Not documented 54 Medication used immediately after arrived at hospital(select all that apply) 55 ☐None 56 57 58 59 13 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 39 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 ☐Diuretics+K 4 ☐ACEI/ARB 5 ☐Beta blocker 6 ☐Aldosterone antagonist among patients with severe HF 7 Oral medications during hospitalization (select all that apply) 8 ☐None ☐Aldosterone antagonist 9 ☐Beta blocker ☐ARB 10 ☐ACE inhibitor ☐Hydralazine nitrate 11 Parenteral therapies during hospitalization (select all that apply) 12 ☐None ☐Nesiritide ☐Dobutamine 13 ☐ ☐ 14 Dopamine Nitroglycerine 15 ☐Milrinone ☐Vasopressin antagonist 16 ☐Loop diureticsFor Intermittent peer bolus reviewContinuous infusion only 17 ☐Other IV vasodilator 18 Was DVT prophylaxis initiated by the end of hospital day 2? 19 Yes No/Not documented Contraindicated 20 If yes, 21 ☐low dose unfractionated heparin (LDUH) 22 ☐Low molecular weight heparin (LMWH) 23 ☐Warfarin 24 ☐Intermittent pneumatic compression devices (IPC) 25 ☐Factor Xa inhibitor 26 ☐ 27 Direct thrombin inhibitor 28 ☐Venous foot pumps (VFP) 29 30 INHOSPITAL COMPLICATIONS 31 DVT or PE (pulmonary embolus) Yes No/Not documented Myocardial infarction Yes No/Not documented 32 http://bmjopen.bmj.com/ 33 Cardiogenic shock Yes No/Not documented 34 Ischemic stroke Yes No/Not documented 35 Bleeding Yes No/Not documented 36 Hemorrhagic stroke Yes No/Not documented 37 38 INHOSPITAL OUTCOMES 39 Length of stay: ______days ICU/CCU duration: ______days Death Yes No Unknown 40 on September 29, 2021 by guest. Protected copyright. 41 If yes, death date/time: ______/______/______: ______42 Primary cause of death 43 Acute coronary syndrome 44 Worsening heart failure 45 Sudden death 46 Hemorrhagic stroke 47 Ischemic stroke 48 Pulmonary embolism 49 Other documented reason: ______50 Unknown 51 DISCHARGE INFORMATION 52 Discharge Date/Time: ______/______/______: ______53 MM/DD/YYYY only 54 Inhospital expense: ______RMB 55 Expense on western medicine ______RMB, TCM ______RMB, Surgery ______RMB 56 Get with the guidelines HF mortality risk score: ______57 58 59 14 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 40 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 What was the patient’s discharge disposition on the day of discharge? 4 Home 5 Other hospital (higherlevel) 6 Other hospital (lowerlevel) 7 Left against medical advice 8 Treatment withdrawal 9 Symptoms (closest to discharge) 10 Worse Unchanged Better, symptomatic Better, asymptomatic Unable to determine 11 Vital Signs (closest to discharge) 12 Weight ______kg Not well documented 13 Heart Rate ______bpm ND 14 BP ______/______mmHg (systolic/diastolic) ND 15 Exam (closest to discharge) 16 The third heart soundFor peer Yes reviewNo Unknown only 17 Jugular venous distension Yes No Unknown 18 Hepatojugular reflux Yes No Unknown 19 Rales Yes No Unknown If yes, <1/3 ≥1/3 N/A 20 Lower extremity edema Yes No Unknown 21 Labs (closest to discharge) Na ______mEq/L Not well documented 22 BNP ______pg/mL Not well documented 23 SCr ______mg/dL Not well documented 24 BUN ______mg/dL Not well documented 25 NTBNP ______pg/mL Not well documented 26 K ______mEq/L Not well documented 27

28 DISCHARGE MEDICATIONS 29 ACEI/ARB 30 Prescribed? Yes No 31 If yes, Medication: Dosage: Frequency:

32 http://bmjopen.bmj.com/ Contraindicated? Yes No 33 Contraindications or Other Documented Reason(s) For Not Providing ACEI: 34 Pregnancy Yes No 35 Allergy Yes No 36 Hyperkalemia Yes No 37 Moderatesevere aortic stenosis Yes No 38 Renal dysfunction Yes No 39 Hypotension Yes No 40 Bilateral renal artery stenosis Yes No on September 29, 2021 by guest. Protected copyright. 41 Breast feeding Yes No 42 Betablocker 43 Prescribed? Yes No 44 If yes, class of Betablocker 45 Evidencebased betablocker Non evidencebased betablocker Unknown class 46 If yes, Medication: Dosage: Frequency: 47 Contraindicated? Yes No 48 Contraindications or Other Documented Reason(s) For Not Providing betablocker: 49 Asthma Yes No 50 Hypotension Yes No 51 Allergy Yes No 52 Bradycardia on day of discharge or day prior to discharge while not on a betablocker 53 Yes No 54 Second or thirddegree heart block and does not have a pacemaker Yes 55 No 56 Patient recently treated with an intravenous positive inotropic agent Yes 57 58 59 15 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 41 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 No 4 Aldosterone antagonists 5 Prescribed? Yes No 6 If yes, Medication: Dosage: Frequency: 7 Contraindicated? Yes No 8 Contraindications or Other Documented Reason(s) For Not Providing Aldosterone 9 antagonists: 10 Hyperkalemia Yes No 11 Renal dysfunction Yes No 12 Allergy Yes No 13 Combination of an ACEI and ARB Yes No 14 Anticoagulant 15 Prescribed? Yes No 16 If yes, class of Foranticoagulant peer review only 17 Warfarin 18 Direct thrombin inhibitor 19 Factor Xa inhibitor 20 Other 21 If yes, Medication: Dosage: Frequency: 22 Contraindicated? Yes No 23 Contraindications or Other Documented Reason(s) For Not Providing Anticoagulant: 24 Risk of bleeding or active bleeding Yes No 25 Allergy Yes No 26 Terminal illness/comfort measures only Yes No 27 Aspirin 28 Prescribed? Yes No 29 If yes, Dosage: Frequency: 30 Contraindicated? Yes No 31 Clopidogrel Prescribed? Yes No

32 http://bmjopen.bmj.com/ If yes, Dosage: Frequency: 33 Other antiplatelet(s) 34 Prescribed? Yes No 35 If yes, Medication: Dosage: Frequency: 36 Hydralazine Nitrate 37 Prescribed? Yes No 38 Contraindicated? Yes No 39 Contraindications or Other Documented Reason(s) For Not Providing Hydralazine

40 on September 29, 2021 by guest. Protected copyright. Nitrate: 41 Symptomatic hypotension Yes No 42 Lupus syndrome Yes No 43 Allergy Yes No 44 Severe renal failure Yes No 45 Diabetic Tx: 46 ☐None prescribed/ND ☐Insulin 47 ☐None contraindicated 48 ☐ 49 Oral agents 50 ☐Other subcutaneous/injectable agents 51 Lipid lowering medication(s) 52 Prescribed? Yes No 53 If yes, Class: Medication: Dosage: Frequency: 54 Class: Medication: Dosage: Frequency: 55 Class: Medication: Dosage: Frequency: 56 Contraindicated? Yes No 57 58 59 16 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 42 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 Other medications at discharge: 4 ☐Antiarrhythmic: 5 Amiodarone Dofetilide Sotalol Other 6 ☐Diuretic: 7 Loop diuretic Thiazide diuretic 8 ☐Nitrate 9 ☐Renin inhibitor 10 ☐Ca channel blocker 11 ☐Digoxin 12 ☐Ranolazine 13 ☐Other antihypertensive 14 15 ☐Other 16 For peer review only 17 OTHER THERAPIES 18 Documented indications for ICD therapy 19 Primary prevention of SCD to reduce total mortality in selected patients with nonischemic DCM or 20 ischemic heart disease at least 40 days postMI with LVEF≤ 35% and NYHA class II or III symptoms on chronic GDMT, who have reasonable expectation of meaningful survival for more than 1 year 21 Secondary prevention in a patient with a ventricular arrhythmia causing hemodynamic instability, 22 who is expected to survive for >1 year with good functional status, or Patient with symptomatic or 23 sustained ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation), reasonable 24 functional status 25 ICD therapy Yes No 26 If no, documented reason(s) for not placing or prescribing ICD therapy? 27 ☐Contraindications 28 ☐Not receiving optimal medical therapy 29 ☐Any other physician documented reason including AMI in prior 40 days, recent 30 revascularization, recent onset of HF 31 ☐Patient declined

32 http://bmjopen.bmj.com/ 33 Documented indications for CRT therapy? 34 Patients in sinus rhythm with NYHA functional class III and ambulatory class IV heart failure and a 35 persistently reduced ejection fraction, despite optimal pharmacological therapy with a QRS duration of 36 ≥120 ms, LBBB QRS morphology, and an EF ≤35%, who are expected to survive with good functional 37 status for >1 year 38 Patients in sinus rhythm with NYHA functional class II heart failure and a persistently reduced 39 ejection fraction, despite optimal pharmacological therapy with a QRS duration of ≥130 ms,

40 on September 29, 2021 by guest. Protected copyright. 41 LBBB QRS morphology, and an EF ≤30%, who are expected to survive for >1 year with good 42 functional status 43 CRT therapy Yes No 44 If no, documented reason(s) for not placing or prescribing CRT therapy? 45 ☐Contraindications 46 ☐Not receiving optimal medical therapy 47 ☐Not NYHA functional Class III or ambulatory Class IV 48 ☐Any other physician documented reason including AMI in prior 40 days, recent 49 revascularization, recent onset of HF 50 ☐QRS duration <120 ms 51 ☐Patient declined 52

53 RISK INTERVENTIONS 54 Smoking cessation counseling given Yes No 55 Activity level Yes No 56 Symptom worsening Yes No 57 58 59 17 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 43 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 Diet (salt restricted) Yes No 4 Medications Yes No 5 Weight monitoring Yes No 6 Followup visit scheduled 7 Yes No 8 9 10 11 12 13 14 15 16 For peer review only 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39

32 • RISK INTERVENTIONS ...... 72 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39

40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 19 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 45 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 5 Recommended Sources 6 ENTRY CRITERIA 7 8 • Patients hospitalized with a discharge diagnosis of HF during the study period. 9 • Aged 18 years or older 10 General notation: 11 12 • ND = Not Documented. Select ND when there is no documentation in the medical record to 13 explain why a treatment or intervention is not performed. 14 • UTD = Unable to determine. 15 • LVF/LVEF= Left Ventricular Function/Left Ventricular Ejection Fraction; LVSF= Left 16 VentricularFor Systolic Functionpeer review only 17 Abstraction Guidelines: 18 19 • Do not enter any personal health information/protected health information (PHI) in any free 20 text "Comments" fields or Optional Fields. 21 • Make use of the Suggested Sources for Abstraction as a guide to help find medical 22 documentation for each data element. Only abstract data that is clearly documented in the 23 medical records. 24 • When there is a discrepancy in documentation status or a patient's specific variable, refer to 25 the source of higher medical authority relevant to that variable. 26 • Date Precision: Date and Time fields have an additional "Precision" dropdown right above the 27 MM/DD/YYYY HH:MI blanks. Data Precision is used to indicate how much of the Date and 28 Time data is known and can be abstracted. For most of the Heart Failure Date and Time fields, there are three Precision levels. The default level is "MM/DD/YYYY HH:MI". This is used if the 29 entire Date and Time information is available. Time should be entered in 24hr format. 30 31 Suggested Sources for Abstraction:

32 http://bmjopen.bmj.com/ 33 • Front page 34 • Discharge records • Admission records 35 • Progress notes 36 • Inhospital procedure report 37 • Echocardiography report 38 • Imaging examination 39 • Inhospital ECG

40 • Physician orders on September 29, 2021 by guest. Protected copyright. 41 • Temperature report 42 • Lab test 43

44 45 ARRIVAL AND ADMISSION INFORMATION 46 47 REQUIRED: Patient ID 48 REQUIRED: Medical Record Number 49 REQUIRED: Admit Date/Time REQUIRED: Department of Admission 50 51 52 53 REQUIRED: Patient ID 54 55 56 The patient identification number is a unique patient ID number assigned to the patient by the site 57 58 59 20 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 46 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 for that admission. Enter the deidentified number in order to track your patient. 4 Source of definition: China PEACE 5 6 REQUIRED: Medical Record Number 7 8 9 Indicate the identification number for this record. 10 11 Front page, Discharge records, Admission records, Progress notes, Physician orders, Temperature report, Lab test 12 13 Source of definition: China PEACE 14 15 REQUIRED: Admit Date/Time 16 For peer review only 17 The month, day, and year of admission to this facility, including hour and minute if available. 18 If the full date and time is known, use the format "YYYY/MM/DD HH24:MI". If the Date is 19 known but the time is unable to determine (UTD), select the format precision " YYYY/MM/DD 20 " in the dropdown just above this field. If the Date is UTD, select the format precision 21 "Unknown". 22 23 Notes for Abstraction: ° The intent of this data element is to determine the date that the patient was actually admitted to 24 this facility. 25 ° For patients who are admitted to Observation status and subsequently admitted to ward, 26 abstract the date that the determination was made to admit to ward and the order was written. 27 Do not abstract the date that the patient was admitted to Observation. 28 ° For patients that are admitted for surgery and/or a procedure, if the admission order states the 29 date the orders were written and they are effective for the surgery/procedure date, then the 30 date of the surgery/procedure would be the admission date. If the medical record reflects that 31 the admission order was written prior to the actual date the patient was admitted and there is

32 no reference to the date of the surgery/procedure, then the date the order was written would http://bmjopen.bmj.com/ 33 be the admission date. 34 Converting clock time to military time: 35  Noon (12:00) and Midnight (00:00): 36  If the time is in the a.m., conversion is not required. 37  If the time is in the p.m., add 12 hours to the clock time 38 39 Front page, Discharge records, Admission records, Progress notes, Temperature report

40 Source of definition: GWTGHF on September 29, 2021 by guest. Protected copyright. 41 42 REQUIRED: Department of Admission 43 44 A code indicates the department responsible for the patient admission. 45 46 Allowable Values: 47 (1) Cardiovascular Department 48 (2) Internal Medicine Department 49 (3) Geriatrics 50 (4) Cadre’s Ward 51 (5) Cardiovascular Intensive Unit/Intensive Care Unit 52 (6) Other 53 (7) Unrecorded 54 Front page 55 Source of definition: China PEACE 56

57 58 59 21 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 47 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 DEMOGRAPHIC DATA 4 5 REQUIRED: Age 6 REQUIRED: Date of Birth REQUIRED: Gender 7 REQUIRED: Ethnicity 8 REQUIRED: Medical Insurance 9 10 REQUIRED: Age 11 12 13 Indicate the age of the patient in years. 14 Front page, Admission records, Progress notes, Temperature report, Discharge records 15 Source of definition: China PEACE 16 For peer review only 17 REQUIRED: Date of Birth 18 19 The month, day, and year the patient was born. Use the format: YYYY MMDD. 20 21 Front page 22 Source of definition: GWTGHF 23 24 REQUIRED: Gender 25 26 Record the patient's gender as Male, Female or Unknown. 27 Notes for Abstraction: 28 29 ° Collect the documented patient’s sex at admission or the first documentation after arrival. 30 ° Consider the sex to be unable to be determined and select “Unknown” if: 31  Documentation is contradictory.  Documentation indicates the patient is a Transexual. 32 http://bmjopen.bmj.com/ 33  Documentation indicates the patient is a Hermaphrodite. 34 All suggested sources. 35 Source of definition: GWTGHF 36 37 REQUIRED: Ethnicity 38 39 Indicate the ethnicity of the patient. The highlighted groups comprise the top 9 ethnicities by

40 population size among 56 ethnic groups within China, including: on September 29, 2021 by guest. Protected copyright. 41 (1) Han 42 (2) Zhuang 43 (3) Man 44 (4) Hui 45 (5) Miao 46 (6) Weiwuer 47 (7) Tujia 48 (8) Yi 49 (9) Buyi 50 (10) Other 51 (11) Unrecorded 52 Front page 53 Source of definition: China PEACE 54 55 56 57 58 59 22 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 48 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 REQUIRED: Medical Insurance 4 5 Indicate the patient’s medical insurance status. Select the type documented. 6 ° Urban Employeebased Basic Medical Insurance (UEBMI): the type of insurance provided 7 by a company or factory for their employees. 8 ° Urban Residentbased Basic Medical Insurance (URBMI): the medical insurance provided 9 by the government for people who live in urban areas. 10 ° Rural New Cooperative Medical scheme (NCMS): the medical insurance funded by the 11 government for farmers. 12 ° Payment OutofPocket: Indicated for those without medical insurance or for whom certain 13 diseases are not covered by insurance. Patient will pay for these costs. 14 ° Free Medical Care: The government provides free medical treatment for a specific group of 15 people such as for disabled members of the armed forces. 16 ° UrbanruralFor Residentbased peer Basic review Medical Insurance : onlya new medical insurance type 17 provided by the government for residents who live in urban and rural areas in some specific 18 regions in China. 19 ° Other Insurance 20 ° Unrecorded 21 Front page 22 Source of definition: China PEACE 23 24 25 DIAGNOSIS 26 27 REQUIRED: Admission Diagnosis 28 REQUIRED: Discharge Diagnosis 29 30 REQUIRED: Admission Diagnosis 31

32 Indicate the admission diagnosis documented in the medical record. Select all that apply: http://bmjopen.bmj.com/ 33 ° Cardiac related: Heart failure, NYHA class, Coronary artery disease, Myocardial infarction, 34 Prior PCI (percutaneous coronary intervention), Unstable angina, Prior MI (myocardial 35 infarction), Prior CABG (coronary artery bypass graft), Valvular heart disease, Congenital 36 cardiac disease, Hypertension, Atrial fibrillation (chronic or recurrent), CRTD (cardiac 37 resynchronization therapy with ICD (implantable cardioverter defibrillator)), CRTP (cardiac 38 resynchronization therapypacing only), Pacemaker, ICD only, Dilated cardiomyopathy, 39 Cardiogenic shock, Prior cardiac valve surgery, Prior heart transplant, Myocarditis, Alcoholic cardiomyopathy, Pulmonary hypertension 40 on September 29, 2021 by guest. Protected copyright. 41 ° Noncardiac related: Hyperlipidemia, Diabetes mellitus, Type 2 diabetes mellitus, Prior 42 cerebrovascular ischemic stroke, Prior cerebrovascular hemorrhagic stroke, Prior unspecific 43 stroke, Acute cerebrovascular ischemic stroke, Acute cerebrovascular hemorrhagic stroke, Acute unspecific stroke, Cancer, Anemia, COPD (chronic obstructive pulmonary disease), 44 Peripheral vascular disease, Chronic renal disease, Liver cirrhosis, Asthma, Pregnancy, 45 Bleeding, Peptic ulcer, Systemic lupus erythematosus, DVT (deep venous thrombosis) or PE 46 (pulmonary embolus), Bilateral renal artery stenosis, Moderatesevere aortic stenosis, 47 Pneumonia 48 Notes for Abstraction: 49 50 ° The NYHA functional classification system relates symptoms to everyday activities and 51 the patient's quality of life. I – No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, 52 palpitation, or dyspnea (shortness of breath) 53 II Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results 54 in fatigue, palpitation, or dyspnea. 55 III Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity 56 causes fatigue, palpitation, or dyspnea. 57 58 59 23 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 49 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 IV Unable to carry out any physical activity without discomfort. Symptoms of cardiac 4 insufficiency present at rest. If any physical activity is undertaken, discomfort is increased. 5 Front page, Discharge records, Admission records 6 Source of definition: China PEACE 7 8 REQUIRED: Discharge Diagnosis 9 10 Indicate the discharge diagnosis documented in the medical record. Select all that apply: 11 ° Cardiac related: Heart failure, NYHA class, Coronary artery disease, Myocardial infarction, 12 Prior PCI, Unstable angina, Prior MI, Prior CABG, Valvular heart disease, Congenital cardiac 13 disease, Hypertension, Atrial fibrillation (chronic or recurrent), CRTD, CRTP, Peacemaker, 14 ICD only, Dilated cardiomyopathy, Cardiogenic shock, Prior Cardiac valve surgeon, Prior heart 15 transplant, Myocarditis, Alcoholic cardiomyopathy, Pulmonary hypertension 16 ° NoncardiacFor related: peerHyperlipidemia, review Diabetes mellitus, Type only 2 diabetes mellitus, Prior 17 cerebrovascular ischemic stroke, Prior cerebrovascular hemorrhagic stroke, Prior unspecific 18 stroke, Acute cerebrovascular ischemic stroke, Acute cerebrovascular hemorrhagic stroke, 19 Acute unspecific stroke, Cancer, Anemia, COPD, Peripheral vascular disease, Chronic renal 20 disease, Liver cirrhosis, Asthma, Pregnancy, Bleeding, Peptic ulcer, Systemic lupus 21 erythematosus, DVT or PE, Bilateral renal artery stenosis, Moderatesevere aortic stenosis 22 Front page, Discharge records 23 Source of definition: China PEACE 24 25 26 MEDICAL HISTORY 27 28 REQUIRED: Medical History REQUIRED: History of Cigarette Smoking? 29 REQUIRED: Etiology of HF 30 OPTIONAL: No. Hospital Admissions in past 6 mo. for HF 31

32 REQUIRED: Medical History http://bmjopen.bmj.com/ 33 34 35 Identify the patient's past medical history from the following list. This should include secondary 36 diagnoses and risk factors that are relevant to this admission. Make the selection even when a 37 condition (for example, Hyperlipidemia) is wellcontrolled or normalized because of ongoing medication or treatment. Select all that apply: 38 ° None: Select if patient has none of the below listed conditions. 39 ° Atrial Flutter (Chronic or Recurrent): Select if the patient has a history of atrial

40 on September 29, 2021 by guest. Protected copyright. flutter. 41 Do not record a history of Atrial Flutter if the only reference to Atrial Flutter history in 42 the medical record indicates: 43 The episode was transient and entirely reversible AND terminated within 8 weeks 44 following CABG. 45 The episode was transient AND entirely reversible due to thyrotoxicosis 46 NOTE: These are the only two circumstances where Atrial Flutter is mentioned in 47 the medical record, but you would not record a history of Atrial Flutter. 48 Any patient with a history of Atrial Flutter who has undergone a procedure for Atrial Flutter 49 such as pacemaker placement or ablation or who is under medical therapy for rhythm 50 control is still considered as having a history of Atrial Flutter, for whom you should select 51 Atrial Flutter under medical history. 52 ° Atrial Fib (Chronic or Recurrent): Select if patient has any prior history of atrial 53 fibrillation (i.e., remote, paroxysmal or persistent.) Do not record a history of Atrial Fib if 54 the only reference to Atrial Fibrillation history in the medical record indicates: 55 The episode was transient and entirely reversible AND terminated within 8 weeks following CABG. 56 The episode was transient AND entirely reversible due to thyrotoxicosis 57 58 59 24 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 50 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 NOTE: These are the only two circumstances where Atrial Fib history is mentioned 4 in the medical record, but you would not record a history of Atrial Fib. 5 Any patient with a history of Atrial Fib who has undergone a procedure for Atrial Fib such 6 as pacemaker placement or ablation or who is under medical therapy for rhythm control is still considered as having a history of Atrial Fib and you should select Atrial Fib under 7 medical history. 8 ° CRTD (cardiac resynchronization therapy with ICD): History of the patient undergoing 9 CRTD (CRT combined with implantable cardioverter defibrillator) prior to the index 10 hospitalization. CRT is also known as BiVentricular Pacing. 11 ° CAD: History of coronary artery disease. Patient has a previous history of any of the 12 following: Coronary artery stenosis 50% (by cardiac catheterization or other modality of 13 direct imaging of the coronary arteries), Previous CABG surgery, Previous PCI, Previous 14 MI. 15 ° CRTP (cardiac resynchronization therapy pacing only): History of the patient having 16 undergoneFor CRTP peer pacing only, reviewprior to the index hospitalization. only CRT is also known as 17 BiVentricular Pacing. 18 ° Dialysis (chronic): Select if the patient has been receiving dialysis treatments for renal 19 disease on a chronic basis (including intraperitoneal dialysis). 20 ° Hypertension: Select if the patient has a history of high blood pressure, regardless of 21 adherence to prescribed medications. Hypertension is a risk factor for the development 22 and progression of coronary disease and heart failure. Defined as systolic blood pressure 23 greater than or equal to 140 mm Hg and diastolic blood pressure greater than or equal to 24 90 mm Hg on multiple readings or confirmed in the medical history. 25 ° Peripheral Vascular Disease: Refers to a history of peripheral vascular disease of the 26 arteries of the extremities, especially conditions that interfere with adequate blood flow to the extremities and occur prior to this acute event. Example: peripheral arterial occlusion. 27 ° Prior PCI: Select if there is a history of Percutaneous Coronary Intervention (PCI) of any 28 type (balloon angioplasty, atherectomy, stent or other) prior to this event. 29 ° Ventricular assist device: History of the patient having received a ventricular assist 30 device prior to the index hospitalization (Right ventricular assist device; Left 31 ventricular assist device; Biventricular assist device; Heart pump; Left ventricular

32 assist system; Implantable ventricular assist device) http://bmjopen.bmj.com/ 33 ° Anemia: History of chronically low hemoglobin. This includes a past medical history 34 of anemia and/or notation of low hemoglobin content. 35 ° Coronary artery disease: History of coronary artery disease. Patient has a previous 36 history of any of the following: Coronary artery stenosis 50% (by cardiac catheterization or 37 other modality of direct imaging of the coronary arteries), Previous CABG surgery, 38 Previous PCI, Previous MI. 39 ° Prior MI: Select if there is a history of a physician diagnosed MI, patient reported history of MI or heart attack, EKG evidence of an old MI prior to this event, or a previous hospital 40 on September 29, 2021 by guest. Protected copyright. 41 admission for MI. 42 ° Diabetes mellitus: History of diabetes, (regardless of disease duration), need for 43 antidiabetic agents, or a fasting blood sugar greater than 7 mmol/l or 126 mg/dl. ° Diabetes Insulin treated: Select if there is a history of physician diagnosed, Insulin 44 dependent diabetes. Do not include diabetes based on a patient's statement of "my sugar 45 has always run high" or based on a single value of elevated blood sugar in the chart. In 46 order to include it, it has to be an actual diagnosis. Diabetes is a CHD risk equivalent and 47 is associated with worse outcomes in patients with heart failure. 48 ° Diabetes nonInsulin treated: Select if there is a history of physician diagnosed, 49 nonInsulin dependent diabetes including the use of diet or oral hypoglycemic agents. Do 50 not include diabetes based on a patient's statement of "my sugar has always run high" or 51 based on a single value of elevated blood sugar in the chart. In order to include it, it has 52 to be an actual diagnosis. Diabetes is a CHD risk equivalent and associated with worse 53 outcomes in patients with heart failure. 54 ° Heart Failure: Physician documentation or report of any of the following symptoms prior 55 to this acute event. Symptoms consistent with a diagnosis of heart failure include unusual 56 dyspnea on light exertion, recurrent dyspnea occurring in the supine position, fluid 57 58 59 25 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 51 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 retention, low cardiac output secondary to cardiac dysfunction; or rales, jugular venous 4 distention (JVD), pulmonary edema, or cardiogenic shock whether or not the patient 5 adheres to prescribed medications. A previous hospital admission with a principal 6 diagnosis of heart failure is considered a heart failure history. 7 ° ICD only: History of the patient having received an implantable cardioverter defibrillator (ICD). Select this field only if an ICD alone without biventricular pacing was placed prior to 8 the index hospitalization (i.e., no CRT). 9 ° Prior CABG: Select if there is a history of Coronary artery bypass graft (CABG) prior to 10 this event. 11 ° Renal Insufficiency chronic (SCr>2.0): Select if there is a history of physician 12 diagnosed renal insufficiency, reduced glomerular filtration rate for at least 3 months or 13 chronic renal failure or if the serum creatinine is greater than 2.0mg/dl. Also select if the 14 patient receive dialysis or has a history of renal transplantation or receives dialysis. 15 ° COPD or Asthma: Refers to evidence or knowledge of chronic obstructive pulmonary 16 diseaseFor prior to peerthis acute event. review This would include COPD,only chronic productive cough, 17 chronic wheezing, chronic asthma, emphysema, chronic bronchitis or currently under 18 chronic treatment of inhaled or oral pharmacological therapy (e.g., betaadrenergic 19 agonist, antiinflammatory agent, leukotriene receptor antagonist, or steroid). 20 ° Stroke: Refers to a history of ischemic stroke, hemorrhagic stroke, subarachnoid 21 hemorrhage, or transient ischemic attack. This diagnosis should be confirmed by a 22 physician. Do NOT select simply based upon a CT or MRI available in the medical record 23 or ICD9/ICD10 codes from prior encounters. 24 ° Dyslipidemia: Defined by the national cholesterol education program criteria and 25 includes at least 1 documentation of the following: 26 Total cholesterol greater than 200mg/mL (5.18mmol/L); Lowdensity lipoprotein (LDL) greater than or equal to 130 mg/dL (3.37mmol/L); 27 Highdensity lipoprotein (HDL) less than 40 mg/dL (1.04mmol/L); 28 Currently on pharmacologic therapy for treatment of dyslipidemia. For patients with 29 known coronary artery disease, treatment is initiated if LDL is greater than 30 100mg/dL (2.59mmol/L), and this would qualify as hypercholesterolemia. 31 ° Pacemaker: History of the patient having received a permanent pacemaker prior to the

32 index hospitalization (ventricular single chamber or atrialventricular dual chamber). Do http://bmjopen.bmj.com/ 33 not select this field if the patient has an implantable cardioverter defibrillator (ICD) or 34 biventricular pacemaker (CRT). 35 ° Valvular Heart Disease: Select if there is a history of valvular heart disease. Valvular 36 heart disease is evidenced by moderately severe or severe (3+ or 4+) aortic insufficiency, 37 moderately severe or severe (3+ or 4+) mitral insufficiency with echocardiographic 38 evidence that mitral insufficiency is a primary abnormality and not secondary to 39 ventricular dilation, moderately severe or severe aortic stenosis (defined by estimated aortic valve area by catheterization or Doppler echocardiography of less than or equal to 40 2 on September 29, 2021 by guest. Protected copyright. 41 1.0 cm , measured by catheterization or Doppler echocardiography), and moderately 42 severe or severe mitral stenosis (defined by estimated mitral valve area by catheterization or echocardiography of less than 1.0 cm2, by catheterization or echocardiography), 43 moderately severe or severe pulmonary or tricuspid valve stenosis or insufficiency, valve 44 disease that is felt to be significant but does not fulfill the above definitions. 45 ° Congenital cardiac disease: History of congenital cardiac lesions including: Patent 46 ductus arteriosus, Atrial septic defect (ASD), Ventricular septal defect (VSD), Tetralogy of 47 Fallot, Transposition of great vessels, Congenitally corrected transposition, Single 48 ventricle, and other congenital cardiac lessions. 49 ° Cancer: Documented history of malignancy (hematological, solid organ, or metastases). 50 Cancer includes carcinoma, sarcoma, melanoma, leukemia (any type), lymphoma, 51 Hodgkin’s disease, myeloma, or malignant tumor. 52 ° Liver Cirrhosis: Documented history of liver cirrhosis. 53 Admission records 54 Source of definition: GWTGHF, China PEACE, 2005 ACC/AHA key data 55 56 57 58 59 26 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 52 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 REQUIRED: History of Cigarette Smoking? 4 5 Indicate the smoking status of the patient. 6 (1) Never smoked 7 (2) Current Smoker. If yes, record the average number of cigarettes smoked per day. 8 (3) Past Smoker: defined as a person who was a daily smoker in the past and stopped smoking at 9 least three months prior to admission date, or chart documentation of “past smoker” 10 (4) Unrecorded 11 Admission records 12 Source of definition: China PEACE 13 14 REQUIRED: Etiology of HF 15 16 Indicate whetherFor the etiology peer is Ischemic/CAD review or NonIschemic. only 17 Ischemic/CAD: The patients HF etiology is ischemic heart disease and may be 18 documented as a history of heart attack, MI, CAD, ischemic cardiomyopathy. 19 NonIschemic: The patients HF etiology is not ischemic heart disease and may be 20 documented as a history of hypertension, alcohol or drug abuse, chemotherapy, viral, 21 postpartum, familial, unknown or idiopathic. 22 Select the most likely nonischemic etiology of the patient's heart failure: 23 ° Cardiomyopathy: History of cardiomyopathy 24 ° Constructive: History of pericardial disease or valvular heart disease or congenital 25 heart disease 26 ° Myocarditis: History of viral heart failure as a cause of the patient's heart failure 27 28 ° Hypertensive: History of hypertension 29 ° Alcohol or drug abuse: History of alcohol/other drugs as a cause of the patient's 30 heart failure 31 ° Chemotherapy or chest radiotherapy: History of chemotherapy or chest

32 radiotherapy as a cause of the patient's heart failure http://bmjopen.bmj.com/ 33 ° Arrhythmic: History of arrhythmia as a cause of the patient's heart failure 34 ° Unknown/Idiopathic 35 ° Other 36 Notes for Abstraction: 37 If it is unclear from the patient's history whether the etiology of the Heart Failure is Ischemic 38 vs. NonIschemic, choose Ischemic. For example, when both hypertension and MI are 39 documented in the patient's history but it is not clear which led to Heart Failure, choose

40 Ischemic. on September 29, 2021 by guest. Protected copyright. 41 Admission records, Progress notes 42 Source of definition: GWTGHF 43 44 OPTIONAL: No. Hospital Admissions in past 6 mo. for HF 45 46 47 Select one of the following options: 0, 1, 2, >2, or Unknown for the total number of hospital 48 admissions in the 6 month period prior to the date of this admission, and not including this admission, in which the patient was admitted to an acute care hospital for heart failure. 49 50 Admission records 51 Source of definition: GWTGHF 52 53 54 CONDITIONS CONTRIBUTING TO HF EXACERBATION 55 56 Select all that apply from the following options: 57 58 59 27 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 53 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 ° Arrhythmia: Heart failure symptoms (dyspnea on exertion, orthopnea, paroxysmal 4 nocturnal dyspnea) worsened by underlying and uncontrolled atrial fibrillation. 5 ° Ischemia/ACS: Heart failure symptoms (dyspnea on exertion, orthopnea, paroxysmal 6 nocturnal dyspnea) worsened by ischemia, unstable angina, acute coronary syndrome, or 7 acute myocardial infarction. 8 ° Pneumonia/respiratory process: Heart failure symptoms (dyspnea on exertion, 9 orthopnea, paroxysmal nocturnal dyspnea) worsened by underlying respiratory 10 process (COPD, bronchitis) or infection (pneumonia). 11 ° Uncontrolled HTN: Heart failure symptoms (dyspnea on exertion, orthopnea, 12 paroxysmal nocturnal dyspnea) worsened by underlying uncontrolled hypertension or 13 patient presenting with worsening heart failure symptoms and hypertensive urgency/emergency. 14 15 ° Worsening renal failure: Worsening renal failure characterized by fluid retention 16 exacerbatingFor heart peer failure. review only 17 ° Noncompliance dietary: Dietary indiscretions (e.g. high sodium intake) 18 exacerbating heart failure. 19 ° Noncompliance medication: Noncompliance with prescribed medications 20 exacerbating heart failure. Other: condition(s) other than those listed contributed to 21 HF exacerbation. 22 Discharge records, Admission records, Progress notes 23 Source of definition: GWTGHF 24 25 26 MEDICATION PRIOR TO ADMISSION 27 28 29 REQUIRED: Medications Used Prior to Admission 30 31 Select all medications that were used prior to admission as delineated in the form. Include only

32 http://bmjopen.bmj.com/ those medications which are part of an outpatient medical regimen prior to presentation to the 33 hospital. The recorded medications should reflect maintenance/ scheduled medications and 34 doses taken by the patient. Do not record medications that have been discontinued more than 14 35 days prior to admission. Do not record additional medications administered after presentation to 36 the hospital. Do not include PRN (Pro re nata) medications unless they have been taken within 14 37 days prior to admission. Options include: 38 ° Patient on no meds prior to admission 39 ° Antiplatelet agent (excluding aspirin)

40 on September 29, 2021 by guest. Protected copyright. ° Aspirin 41 42 ° Beta blocker 43 ° Ca channel blocker 44 ° Diabetic Medications (Any) 45 ° Digoxin 46 ° Nitrate 47 ° Hydralazine 48 49 ° Omega3 fatty acid supplement 50 ° Renin Inhibitor 51 ° Anticoagulation Therapy: warfarin/direct thrombin inhibitor/factor Xa inhibitor /other 52 ° Diuretic: thiazide/thiazidelike/loop 53 ° Lipid lowering agent: statin/other lipid lowering agent 54 ° Other 55 56 Admission records 57 58 59 28 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 54 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 Source of definition: GWTGHF 4 5 EXAMS/LABS AT ADMISSION 6 7 OPTIONAL: Symptoms (Closest to Admission) 8 OPTIONAL: Vital Signs (Closest to Admission) 9 OPTIONAL: Exam (Closest to Admission) 10 OPTIONAL: Lipids OPTIONAL: Labs (Closest to Admission) 11 OPTIONAL: Chest Xray 12

13 14 Note: If your documented measurement value has additional decimal positions, please round to the nearest acceptable value. 15 16 OPTIONAL: SymptomsFor (Closest peer to Admission) review only 17 18 19 Select all patient symptoms present at the time of admission: 20 ° Chest pain: patient experiencing chest pain 21 ° Dyspnea at rest: patient experiencing difficulty breathing while at rest 22 ° Orthopnea: patient experiencing difficulty breathing unless sitting straight or standing 23 erect 24 25 ° Dyspnea on exertion: patient experiencing difficulty breathing on exertion 26 ° Paroxysmal nocturnal dyspnea: patient experiencing acute dyspnea at night caused 27 by pulmonary congestion 28 ° Palpitations: patient experiencing unpleasant sensations of irregular and/or forceful 29 beating of the heart 30 ° Fatigue: patient experiencing fatigue 31 ° Decreased appetite/early satiety: patient experiencing decreased appetite or early

32 satiation http://bmjopen.bmj.com/ 33 ° Dizziness/lightheadedness/syncope: patient experiencing dizziness, 34 lightheadedness or syncope 35 Admission records 36 Source of definition: GWTGHF 37 38 OPTIONAL: Vital Signs (Closest to Admission) 39

40 on September 29, 2021 by guest. Protected copyright. 41 Record vital signs closest to the time of admission. 42 ° Weight: enter the height and weight of the patient closest to time of admission. 43 Indicate if these are measured in cm or kg. 44 ° Heart Rate (Required): in beats/minute 45 ° BP (Required): in mmHg (systolic/diastolic). Note: Indicate the first measurement or 46 earliest record of blood pressure 47 ° Respiratory Rate: in breaths per minute 48 Admission records 49 Source of definition: China PEACE 50 51 OPTIONAL: Exam (Closest to Admission) 52 53 54 Indicate the physical findings at the time of admission: 55 ° The third heart sound: Select Yes, No or Unknown. 56 ° Jugular vein distension: Select Yes, No or Unknown. 57 58 59 29 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 55 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 ° Hepatojugular reflux: Select Yes, No or Unknown. 4 ° Rales: Select Yes or No. If Yes, select greater than or equal to 1/3, <1/3 or N/A. 5 ° Lower Extremity Edema: Select Yes or No. 6 Admission records 7 Source of definition: China PEACE 8 9 OPTIONAL: Lipids 10 11 For the measurements in this section, enter the highest level within the first 48 hours or when 12 available. If Lipid values are not available, check the "Lipids Not Available" box. 13 14 Admission records, Progress notes, Lab test 15 Source of definition: GWTGHF 16 For peer review only 17 OPTIONAL: Labs (Closest to Admission) 18 19 Enter the lab values for Na, Hgb, Albumin, BNP, NTBNP, Scr, BUN, Troponin, K, HBA1C, 20 Fasting Blood Glucose (mg/dL). All of the labs are based on the most recent results 21 obtained at index hospitalization closest to the time of admission, except for Troponin 22 which is based on the peak value during this hospitalization. If a lab value is not 23 available, check the "Not Available" checkbox. 24 Notes for Abstraction: 25 ° The intent of this data element is to obtain the lab values that were measured as part 26 of the initial patient evaluation. 27 • Values obtained greater than 48 hours after arrival are not considered admission 28 labs. Do not enter lab values as admission if they were not obtained as part of the 29 initial evaluation. 30 • If there is more than 1 measurement for any lab value as part of the initial 31 evaluation, enter the first measurement obtained.

32 • For lab values that are collected at admission and discharge (Na, BNP, SCr, http://bmjopen.bmj.com/ 33 BUN, NTBNP, and K), if a single measurement is obtained during the 34 hospitalization DO NOT enter the value in both admission and discharge. If the 35 values are obtained greater than 48 hours after arrival DO NOT enter as 36 admission labs. See Labs (closest to discharge) to determine if these values 37 should be entered as discharge labs. 38 ° Na: indicate whether the value is in mEq/L, mg/dL or mmol/L. 39 ° Hgb: indicate whether the value is in g/dL or mg/dL.

40 ° Albumin: indicate in g/dL or g/L on September 29, 2021 by guest. Protected copyright. 41 ° BNP (B type natriuretic peptide): indicate whether the value is in pg/mL, pmol/l or 42 ng/L. 43 44 ° NBNP (Nterminal pro BNP): indicate whether the value is in pg/mL or ng/L. 45 ° SCr (serum creatinine): indicate whether the value is in pg/mL or ng/L. 46 ° BUN (blood urea nitrogen): indicate whether the value is in mg/dL or mol/L 47 ° Troponin (peak): If cardiac troponin results are recorded, indicate if the tests were 48 Troponin I or T and whether the value is in ng/mL or ug/L. Indicate whether the result 49 was considered Normal or Abnormal based on the institution's reference laboratory. 50 ° K: Serum potassium level.. Indicate whether the value is in mEq/L, mg/dL or mmol/L. 51 ° HbA1C: Hemoglobin A1C (glycosylated hemoglobin). Enter as a percent. 52 ° Fasting Blood Glucose: Enter in mg/dL. 53 54 Admission records, Progress notes, Lab test 55 Source of definition: GWTGHF 56 57 58 59 30 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 56 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 OPTIONAL: Chest Xray 4 5 Indicate the diagnosis on chest Xray report at admitting hospital. 6 ° Pulmonary edema 7 8 ° Pulmonary congestion 9 ° Bilateral pleural effusion 10 ° Cardiomegaly/cardiothoracic ratio 11 ° Not Available 12 Admission records, Progress notes, Imaging examination 13 Source of definition: China PEACE 14

15 16 For peer review only 17 INHOSPITAL CARE 18 REQUIRED: EKG QRS Duration (ms) 19 REQUIRED: EKG QRS Morphology 20 OPTIONAL: Other Test 21 OPTIONAL: Procedures 22 REQUIRED: Ejection Fraction Quantitative 23 REQUIRED: Ejection Fraction Qualitative 24 REQUIRED: Documented LVSD 25 REQUIRED: LVF Assessment 26 OPTIONAL: Medication used immediately after arrived at hospital 27 REQUIRED: Oral Medications during Hospitalization OPTIONAL: Parenteral Therapies during hospitalization 28 REQUIRED: Was DVT prophylaxis initiated by the end of hospital day two? 29 30 REQUIRED: EKG QRS Duration (ms) 31

32 http://bmjopen.bmj.com/ 33 The QRS duration measured on the resting EKG in milliseconds (ms). The upper limit of 34 normal duration of the QRS is less than 120 milliseconds. QRS duration is looking for the 35 intrinsic or native duration, so if the patient is paced, you should still enter their QRS 36 duration. 37 38 REQUIRED: EKG QRS Morphology 39

40 Select the appropriate QRS morphology. If there is an official signed EKG read by the on September 29, 2021 by guest. Protected copyright. 41 cardiologist, use that. In the absence of an official signed, physician read EKG, the machine 42 read or abstractor interpretation is acceptable. 43  Normal – Select “Normal” if the patient has normal QRS morphology as determined by 44 initial EKG. 45 ° If the patient's initial EKG shows arrhythmia (i.e atrial fibrillation) or an EKG abnormality 46 other than one of the QRS morphologies listed below, select "Normal". This data 47 element only captures abnormalities of prolonged QRS meeting RBBB, LBBB, NSIVCD 48 criteria or Paced rhythm and no other possible EKG abnormalities. 49 ° Left anterior fascicular block without presence of prolonged QRS meeting RBBB criteria 50 should be classified as "Normal" QRS morphology. 51  RBBB (Right Bundle Branch Block) – Select “RBBB” if the patient’s initial EKG shows 52 Right Bundle Branch Block or incomplete Right Bundle Branch Block. Right Bundle Branch 53 Block is indicated by a Broad QRS >120 ms, RSR’ pattern in V13 (‘Mshaped’ QRS 54 complex) and Wide, slurred S wave in the lateral leads (I, aVL, V56). 55  LBBB (Left Bundle Branch Block) – Select “LBBB” if the patient’s initial EKG shows Left 56 Bundle Branch Block or incomplete Left Bundle Branch Block. Left 57 58 59 31 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 57 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3  Bundle Branch Block is indicated by a QRS duration of at least 120 ms, Dominant S 4 wave in V1, Broad monophasic R wave in lateral leads (I, aVL, V5V6), Absence of Q 5 waves in lateral leads (I, V5V6; small Q waves are still allowed in aVL), and Prolonged R wave peak time > 60ms in left precordial leads (V56). 6 7  NSIVCD (Nonspecific IntraVentricular Conduction Delay) – Select “NSIVCD” if the 8 patient has a Nonspecific IntraVentricular Conduction Delay. NSIVCD is a QRS widening of at least 120 ms that does not meet criteria for LBBB or RBBB. 9 10  Paced – Select “Paced” if patient is in paced rhythm for the QRS complex (ventricular 11 pacing). 12  Not Available – Select “Not Available” if initial EKG findings for QRS morphology are not 13 available for the patient. 14 Admission records, Progress notes, Inhospital ECG 15 Source of definition: GWTGHF 16 For peer review only 17 OPTIONAL: Other Test 18 19 Indicate whether the patient underwent following tests or not between arrival at admitting 20 hospital and discharge. Select all that documented. 21 ° Cardiac magnetic resonance imaging: magnetic resonance imaging (may include 22 angiography) of the heart. 23 ° Cardiac computerized axial tomography: computerized axial tomography of the heart. 24 25 ° Coronary computerized axial tomography: computerized axial tomography of the coronary 26 artery. 27 ° Heart biopsy: Biopsy of the endomyocardium. 28 ° Cardiac positron emission tomography: Positron emission tomography of the myocardium 29 including perfusion imaging and stress studies. 30 ° Stress testing: Cardiovascular stress test including exercise (treadmill, bicycle) and 31 pharmacological stress.

32 ° 6minute walk test: Distanced walked during 6minute walk (on a flat surface), in feet or http://bmjopen.bmj.com/ 33 meters. If yes, record the distance 34 ° Continuous ambulatory ECG monitoring for HF: Specify type of ambulatory ECG monitor used 35 (e.g., looping event monitor, implantable looping event monitor, Holter monitor). 36 ° Radionuclide ventriculography: Cardiac blood pool imaging (first pass or gated 37 equilibrium) with or without stress. 38 Admission records, Progress notes, Imaging examination 39 Source of definition: 2005 ACC/AHA key data

40 on September 29, 2021 by guest. Protected copyright. 41 OPTIONAL: Procedures 42 43 44 Select all procedures that were performed during this admission. 45 ° No Procedures: The patient did not undergo any of the specified procedures. 46 ° Cardiac Cath/Coronary angiography: Patient has undergone a coronary 47 angiography. 48 ° Cardioversion: Patient has undergone intentional therapy (electrical or chemical) of 49 a cardiac arrhythmia. 50 ° Dialysis: Select if the patient has been receiving dialysis. Ultrafiltration: Renal 51 dialysis initiated on this admission. Used in CHF patients who have excess fluid 52 buildup and are refractory (not adequately responsive) to diuretics or are having 53 adverse effects from diuretics. 54 ° Intraaortic balloon pump: Intraaortic balloon pump used at any time during this 55 admission. 56 ° Left Ventricular assist device: a mechanical pump that is surgically implanted under the 57 58 59 32 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 58 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 ribs, where it can help a weakened heart pump blood. It is generally used as a temporary 4 measure in order to keep a patient well long enough to receive a heart transplant. 5 ° Pacemaker: Refers to an actual episode of artificial pacing; transvenous, 6 transthoracic, or external, either temporary or permanent. 7 ° CRTD (cardiac resynchronization therapy with ICD): Patient has undergone 8 CRTD pacing with ICD. CRT is also known as BiVentricular Pacing. 9 ° CRTP (cardiac resynchronization therapy pacing only): Patient has undergone 10 CRTP pacing only. CRT is also known as BiVentricular Pacing. 11 ° PCI: Percutaneous coronary intervention includes techniques capable of relieving 12 coronary narrowing (rotational atherectomy, directional atherectomy, extraction 13 atherectomy, laser angioplasty, implantation of intracoronary stents and other 14 catheter devices for treating coronary atherosclerosis). PTCA (Percutaneous 15 transluminal coronary angioplasty) refers to those studies using primarily balloon angioplasty while PCI refers to the broader group of percutaneous techniques. 16 For peer review only 17 ° Atrial Fibrillation Ablation or Surgery: Patient has undergone catheter based atrial 18 fibrillation ablation including radiofrequency ablation, cryoablation, or other techniques or atrial fibrillation surgery including MAZE, other surgical techniques, and ablation applied 19 during surgery. 20 21 ° Cardiac Valve Surgery: A heart valve repair can be performed on a valve that is too narrow to allow sufficient blood to flow through the valve opening (stenosis) or on a valve 22 that cannot close tightly enough to prevent back flow of blood (insufficiency). A heart 23 valve replacement is performed when a diseased valve that cannot be repaired is 24 removed and replaced with a substitute mechanical or biological valve. 25 ° Coronary artery bypass graft: Patient has undergone a coronary artery bypass 26 graft (CABG). 27 ° ICD only: Indicates that the physician has placed an implantable cardiac defibrillator. The 28 device allows physicians to perform only one operation on patients who need both 29 defibrillators and pacemakers. 30 ° Mechanical ventilation: Patient has had breathing sustained by means of a 31 ventilator during this admission.

32 http://bmjopen.bmj.com/ ° Right Cardiac Catheterization: Refers to the placement of a pulmonary artery 33 catheter such as a SwanGanz catheter to monitor right heart pressures. 34 ° Transplant (Heart): Patient has received a heart transplant on this admission. 35 36 Discharge records, Progress notes, Inhospital procedure report 37 Source of definition: GWTGHF 38 39 REQUIRED: Ejection Fraction Quantitative

40 on September 29, 2021 by guest. Protected copyright. 41 Enter the ejection fraction as a twodigit %. EF is defined as the proportion of blood ejected during 42 each ventricular contraction compared with the total ventricular filling volume. 43 The ejection fraction is an index of ventricular function. If a numeric value has been recorded, 44 enter here as a twodigit %. If description was recorded, enter it in the Ejection Fraction 45 Qualitative question. Indicate whether this value was obtained during this admission, within the 46 last year, or more than 1 year ago. 47 Notes for Abstraction: 48 ° If both a numeric value and narrative description are documented in reference to the 49 same LVF/LVEF assessment, use the numeric value. 50 ° The numeric EF may be documented as a percentage (%), whole number, or decimal. 51 Convert all decimals to percentages (e.g., 0.40 = 40). The value should be between 5 52 and 80. 53 ° If EF was reported as a range, use the midpoint and consider this an estimated value 54 (e.g., LVEF of 3545%. Use 40% as an estimated EF value). 55 ° If the LV Function has been determined twice during the admission, enter the results of 56 the test closest to the day of discharge. If unable to determine which assessment was 57 58 59 33 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 59 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 performed closest to the day of discharge, use the lowest or most severe LVF/LVEF. 4 ° If two or more numeric values or descriptions are provided in reference to the same 5 LVF/LVEF assessment, use the lowest value or most severe description. 6 ° If both calculated and an estimated value are documented, use the calculated value. 7 ° If the EF is documented as less than (<) or greater than (>) a given number, use the value 8 one whole number below or above the given number (e.g., EF < 40% Use 39%; EF > 9 40% Use 41%). 10 ° If the EF is not documented as a whole number, round fractions to the nearest whole 11 number (e.g., 39.5% = 40%, 39.4% = 39%) 12 Echocardiography report, Discharge records, Progress notes, Imaging examination 13 Source of definition: GWTGHF 14 15 REQUIRED: Ejection Fraction Qualitative 16 For peer review only 17 18 Enter the Ejection Fraction description. Terms such as below normal, poor, or above normal 19 which are recorded in lieu of the percentage should be selected from the dropdown list here. If a 20 numeric value has been recorded, enter it in the Ejection Fraction Quantitative question as a twodigit %. Indicate whether this value was obtained during this admission, within the last year, 21 or more than 1 year ago. 22 Severity Classifications/Descriptions: 23 24 25 ° Normal or mild dysfunction: includes normal, good, adequate, at the lower limits of normal, borderline normal, good, hyperkinetic, intact, left ventricle described as 26 normal/good, normal, preserved, satisfactory, wall motion described as normal/good, 27 within normal limits, mild, mildmoderate. 28 ° Qualitative moderate/severe dysfunction: includes moderatesevere, low, abnormal, 29 compromised, decreased, depressed, diffuse hypokinesis (degree of severity not 30 specified), diminished, dysfunction (degree of severity not specified), generalized 31 hypokinesis (degree of severity not specified), impaired, low, moderate, moderately

32 severe, reduced, significant, very severe, very low, poor, global, marked, very low, very http://bmjopen.bmj.com/ 33 poor, very severe. 34 ° Not Performed: if an LVF/LVEF was not performed during hospitalization and there 35 are no physician documented plans to perform an assessment after discharge. 36 A common question is, if an EF was not measured during this admission, how far back prior to 37 hospital admission may we take a documented EF value? (Example, patient admitted with CAD in 38 February, but had EF measured two months earlier in December admission.) The answer is that, 39 if the reason EF was not measured during this admission was because clinicians decided the earlier EF assessment was sufficient to make their decisions, then the earlier assessment should 40 on September 29, 2021 by guest. Protected copyright. 41 be entered. 42 Echocardiography report, Discharge records, Progress notes, Imaging examination 43 Source of definition: GWTGHF 44 45 REQUIRED: Documented LVSD 46 47 Left ventricular systolic dysfunction (LVSD) documented in medical record. LVSD is defined as a 48 left ventricular ejection fraction less than 40% or a narrative description consistent with moderate 49 or severe systolic dysfunction. 50 LVSD is an impairment of left ventricular contractile performance. An EF is an index of left 51 ventricular systolic function (LVSF) and reflects the proportion of blood ejected during each 52 ventricular contraction compared with the total ventricular filling volume. 53 ° Select Yes if LVSF is documented as an EF less than 40% or a narrative description 54 consistent with moderate or severe systolic dysfunction. 55 ° Select No if LVSF is not documented as an EF less than 40% or a narrative description 56 not consistent with moderate or severe systolic dysfunction, or unable to determine from 57 58 59 34 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 60 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 medical record documentation (e.g., LVSF assessment was never done, Echo done last 4 March [without mention of LVSF results]). 5 Notes for Abstraction: 6 7 ° Results from an inhospital LVSF assessment test performed during the hospitalization 8 that may have been filed into the chart after discharge should still be used. 9 A. Methodology: 10 11 Final findings take priority over preliminary findings. Applies to test reports and findings 12 noted outside of reports. If not labeled “preliminary,” assume it is final. Conclusion section of report takes priority over other sections. Consider the “Impression,” “Interpretation,” 13 and “Final Diagnosis” sections as equivalent with the “Conclusion” section. 14 15 1. If one or more inhospital tests performed: 16  ForUse report peer from most recent review test*(test done closestonly to discharge). 17  If no report or no EF/LVSF findings noted in report, use other sources (e.g., 18 progress notes) that clearly reference the most recent test *. 19  If no EF/LVSF results from the most recent test are documented anywhere, 20 use the report from the second most recent test*. 21  If no EF/LVSF findings from second most recent test documented anywhere, use 22 other sources (e.g., progress notes) that clearly reference the second most recent 23 test*. Continue working backwards (if > 2 tests) and use EF/LVSF from the most recent 24 test* that has EF/LVSF findings, using the report over nonreport sources as above. 25  If no EF/LVSF results from any inhospital test are documented anywhere, 26 skip to step 2a below. 27 *If you cannot determine between two inhospital tests which was performed 28 closest to the time of discharge, use BOTH tests: 29 1) Use reports. Reports take priority over nonreport sources. 30 2) If no reports or no EF/LVSF findings on reports from any test, use other 31 sources (e.g., progress notes) that clearly reference the tests.

32 3) If no EF/LVSF results from either inhospital test documented anywhere, go http://bmjopen.bmj.com/ 33 to step 2a below. 34 2. If inhospital test not done, no EF/LVSF results from any inhospital test 35 documented, OR documentation is not clear that one was done (e.g., echo ordered 36 but no documentation that it was done): 37 a. Assume notations of EF/LVSF with no timeframe (“floating” EFs/LVSFs) are from 38 assessments done prior to arrival. 39 b. If timeframe known for ALL prearrival EFs/LVSFs (no “floaters”):

40  Use results from the prearrival test known to be most recent (closest to on September 29, 2021 by guest. Protected copyright. 41 hospital arrival). Use report over other sources, and Conclusion (Impression, 42 etc.) over other sections of report, as above. 43 c. If one or more “floaters”: 44  Compile all EFs/LVSFs and eliminate those that you can determine are 45 not the most recent, resulting in a list of EF/LVSF “Possibles.” 46  If EF/LVSF from one test in the “Possibles” list is referenced both in a 47 report and in another source, use the report, and use the Conclusion 48 (Impression, etc.) over other sections of the report, as above, to determine 49 which EF/LVSF from this test to add to the list of “Possibles.” 50  Select final EF/LVSF from list of “Possibles” based on the Conflicting 51 Documentation rules below. 52 B. Conflicting documentation: 53 54 Apply the following priority order in cases of conflicting documentation within ANY ONE 55 STEP in Methodology above (except 3d), where there are two or more different 56 descriptions of EF/LVSF: 57 58 59 35 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 61 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 #1. Use lowest calculated EF. Presume calculated unless described as estimated (e.g., 4 “EF 30%”). 5 ° If calculated EF < 40%, select “Yes.” If calculated EF ≥ 40%, select “No.” 6 #2. Use lowest estimated EF. E.g., “EF about 40%,” “EF approximately 30%,” “EF 7 appears to be 35%,” “Visually EF is 45%,” “EF 35 – 40%” (use midpoint), “EF < 40%”. 8 ° If estimated EF < 40%, select “Yes.” If estimated EF ≥ 40%, select “No.” 9 #3. Use worst narrative description with severity specified. 10 ° Select “Yes” if description is synonymous with term from Inclusion list A. 11 ° Select “No” if description with severity specified is NOT synonymous with term from 12 Inclusion List A (e.g., normal, mild, preserved). 13 #4. Use narrative description without severity specified. Select “Yes” if description is 14 synonymous with term from Inclusion list B. Otherwise, select “No.” 15 16 For peer review only 17 Inclusion Exclusion 18 Inclusion list A: Moderate/severe LVSD Moderate or severe systolic dysfunction 19 ° Biventricular dysfunction described as marked, moderate, moderatesevere, ° Any term in Inclusion list A or B 20 severe, significant, substantial, or very severe described using the negative modifiers 21 ° Biventricular heart failure described as moderate or severe ° Any term in Inclusion list A or B 22 ° Ejection fraction or left ventricular ejection fraction (LVEF) described as low, poor, described as mildmoderate or very low Endstage cardiomyopathy 23 24 ° Hypokinesis described as diffuse, generalized, or global AND not mild 25 ° Left ventricular (LV) akinesis described as marked, moderate, moderatesevere, 26 severe, significant, substantial, or very severe 27 ° Left ventricular dysfunction (LVD), left ventricular systolic dysfunction (LVSD), or systolic dysfunction described as marked, moderate, moderatesevere, severe, 28 significant, substantial, or very severe 29 ° Left ventricular function (LVF), left ventricular systolic function (LVSF), or systolic 30 functiondescribed as low, poor, or very low 31 ° Left ventricular (LV) hypokinesis described as involving the entire left ventricle OR

32 described as marked, moderate, moderatesevere, severe, significant, substantial, http://bmjopen.bmj.com/ 33 or very severe in one or more segments of left ventricle 34 ° Left ventricular systolic failure described as marked, moderate, moderatesevere, severe, Qualifiers and Modifiers Table significant, substantial, or very severe AND 35 not described as right ventricular 36 Inclusion list B: LVSD – Severity not specified 37 ° Biventricular dysfunction where severity is not specified 38 ° Left ventricular dysfunction (LVD), left ventricular systolic dysfunction (LVSD), or 39 systolic dysfunction where severity is not specified

40 ° Left ventricular systolic failure where severity is not specified on September 29, 2021 by guest. Protected copyright. 41 ° Ejection fraction or left ventricular ejection fraction (LVEF) described as abnormal, 42 compromised, decreased, depressed, diminished, impaired, or reduced 43 ° Left ventricular function (LVF), left ventricular systolic function (LVSF), or systolic 44 function described as abnormal, compromised, decreased, depressed, diminished, 45 impaired, or reduced AND not described as right ventricular 46 47 Guidelines for Abstraction: 48 49 Echocardiography report, Discharge records, Progress notes, Imaging examination 50 Source of definition: GWTGHF 51 52 REQUIRED: LVF Assessment 53 54 Documentation that left ventricular systolic function (LVSF) was assessed either prior to arrival, 55 during hospitalization, or is planned for after discharge or reason documented by physician for not 56 assessing LVSF prior to arrival, during hospitalization, or planned for after discharge. LVSF 57 58 59 36 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 62 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 assessment is a measure of left ventricular contractility, and may be described either 4 quantitatively (e.g., left ventricular ejection fraction = 30%) or qualitatively (e.g., moderate left ventricular systolic dysfunction). 5 6 ° Select Yes if there is documentation in the medical record that the LVSF was 7 assessed prior to arrival, during the hospital stay, or is planned for after discharge. 8 ° Select No if there is no documentation that LVSF was assessed either prior to arrival 9 or during this hospital stay nor a plan to assess LVSF after discharge, AND there is no 10 reason documented by a physician, or unable to determine from medical record documentation. 11 12 ° Select Not Done, Reason Documented if there is a medical reason documented by 13 physician for not assessing LVSF prior to arrival, during hospital stay, or planned after discharge 14 15 Notes for Abstraction: 16 For peer review only 17 ° LVSF assessments done anytime prior to hospital arrival are acceptable (see Inclusion list). 18 19 ° Infer a test was done if the patient's LVSF is documented (e.g., “Pt. admitted with 20 severe LV dysfunction”). 21 ° Consider LVSF assessment as planned for after discharge only if a definitive plan is 22 documented (e.g., “Will do echo as outpatient”). Documentation which only indicates that 23 an LVSF assessment after discharge will be considered as not sufficient. 24 ° In determining whether there is a reason documented by a physician for not 25 assessing LVSF: 26  Reasons must be explicitly documented (e.g., “ESRD. Will not measure EF,” echo 27 results reported as “Technically difficult study. LVSF could not be measured.”) or 28 clearly implied (e.g., “Patient refusing echo,” “Limited life expectancy. Will not do any further evaluation,” “EF measurement not indicated”). 29 30  Physician deferral of LVSF assessment to another physician does NOT count 31 as a reason for not assessing LVSF unless the reason/problem underlying the deferral is also noted (e.g., “Consulting cardiologist to evaluate pt. for echo” – 32 select “No.”). http://bmjopen.bmj.com/ 33 ° If there is documentation of both a reason for not assessing LVSF AND 34 documentation that LVSF was assessed or that assessment is planned for after 35 discharge, select “Yes”. 36 ° In determining whether there is a plan to assess LVSF after discharge, the plan must 37 be documented as definitive (e.g., “Will measure EF after discharge”). 38 Documentation which only indicates that an LVSF assessment after discharge will 39 be considered as (e.g., “May do echo in 1 month”) not sufficient.

40 Guidelines for Abstraction: on September 29, 2021 by guest. Protected copyright. 41 42 Inclusion Exclusion 43 Left ventricular systolic function (LVSF) assessment Left ventricular systolic function (LVSF) 44 Echocardiogram (echo) ° Akinesis not described as left 45 ° Cardiac ultrasound ventricular 46 ° Transesophageal echo (TEE) ° Cardiomyopathy not described as end 47 stage ° Transthoracic echo (TEE) 48 ° Contractility/ hypocontractility Cardiac Catheterization (cath) with Left Ventriculogram (LV gram) 49 ° Dyskinesis not described as left ° Cardiac cath with mention of LVSF 50 ventricular Cardiac/coronary angiogram/arteriogram with LV gram or mention of LVSF 51 ° ° Hypokinesis not described as left 52 ° Left heart cath with mention of LVSF ventricular 53 ° Left ventriculogram (LV gram) ° Left ventricular compliance 54 Other LVSF Assessment Tests ° Left ventricular dilatation/ dilation 55 ° Cardiac MRI scan with mention of LVSF ° Left ventricular hypertrophy (LVH) 56 ° CT scan of chest with mention of LVSF 57 58 59 37 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 63 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 ° Multiple gated acquisition scan (MUGA) or other cardiac imaging/testing 4 described as gated or blood pool 5 ° Other nuclear test (e.g., SPECT, PET) with mention of LVSF 6 Left Ventricular Systolic Function (LVSF) 7 ° A kinesis described as left ventricular 8 ° Diastolic dysfunction, failure, function, or impairment 9 ° Dysfunction described as biventricular, left ventricular (LVD, LVSD), systolic, 10 or ventricular 11 ° Dyskinesis described as left ventricular 12 ° Ejection fraction (EF, LVEF) 13 ° End stage cardiomyopathy 14 ° Failure described as biventricular, left ventricular, systolic, or ventricular 15 16 ° Function described as biventricular, left ventricular (LVF), systolic, or ventricular For peer review only 17 ° Hypokinesis described as left ventricular 18

19 20 Echocardiography report, Discharge records, Progress notes, Imaging examination 21 Source of definition: GWTGHF 22 23 OPTIONAL: Medication used immediately after arrival at hospital 24 25 Indicate if the patient received medication from the list provided immediately after arrived at 26 hospital. Check all that apply. 27 ° None 28 ° Diuretics + K 29 30 ° ACEI/ ARB 31 ° Beta Blocker

32 ° Aldosterone Antagonist among patients with severe HF http://bmjopen.bmj.com/ 33 Physician orders, Discharge records, Progress notes 34 35 REQUIRED: Oral Medications during Hospitalization 36 37 38 Select all oral medications that were administered during hospitalization: 39 ° None: Select "None" if none of the following medications was administered during the hospitalization. 40 on September 29, 2021 by guest. Protected copyright. 41 ° ACE Inhibitor: Documentation that angiotensin converting enzyme inhibitor (ACEI) 42 was prescribed to a patient with heart failure during hospitalization. 43 ° ARB: Documentation that an angiotensin receptor blocker (ARB) was prescribed to a 44 patient with heart failure during hospitalization. 45 ° Beta Blocker: Documentation that Beta Blocker was prescribed during 46 hospitalization to a patient with heart failure. 47 ° Aldosterone Antagonist: Documentation that aldosterone antagonist was prescribed 48 to a patient with heart failure during hospitalization. Aldosterone antagonist is 49 reasonable in selected patients with moderately severe to severe symptoms of heart 50 failure and reduced LVEF who can be carefully monitored for preserved renal 51 function and normal potassium concentration. Under circumstances where monitoring for hyperkalemia or renal dysfunction is not anticipated to be feasible, the 52 risks may outweigh the benefits of aldosterone antagonists. 53 54 ° Hydralazine and isosorbide dinitrate: Documentation that Hydralazine and isosorbide dinitrate was prescribed to a patient with heart failure during 55 hospitalization. Note: this treatment is recommended in addition to ACEI or ARB and 56 beta blocker therapy at discharge. 57 58 59 38 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 64 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 Physician orders, Discharge records, Progress notes 4 Source of definition: GWTGHF 5 6 OPTIONAL: Parenteral Therapies during hospitalization 7 8 Indicate if the patient received an intravenous vasoactive medication from the list provided. 9 Check all that apply. 10 ° None 11 12 ° Dobutamine 13 ° Dopamine 14 ° Loop Diuretics (furosemide [lasix], torsemide [demadex], bumetanide [bumex], 15 ethacrynic [edecrin]) 16  IntermittentFor boluspeer review only 17  Continuous infusion 18 ° Milrinone 19 ° Nesiritide 20 21 ° Nitroglycerine 22 ° Other IV vasodilator (nitroprusside [nipride], IV hydralazine [apresoline], prostacyclin 23 [flolan]) Vasopressin antagonist (conivaptan [vaprisol]) 24 Physician orders, Discharge records, Progress notes 25 Source of definition: GWTGHF 26 27 REQUIRED: Was DVT prophylaxis initiated by the end of hospital day two? 28 29 30 Determine if medication and/or devices were ordered and initiated by the end of hospital day two for prophylaxis against the formation of deep venous thrombosis. 31  Yes: 32 http://bmjopen.bmj.com/ 33  No/Not Documented 34  Contraindicated 35 Inclusion: 36 1. Low dose unfractionated heparin (LDUH) 37 2. Low molecular weight heparin (LMWH) 38 3. Warfarin 39 4. Intermittent pneumatic compression devices (IPC): AE pumps (antiembolic 40 pumps)calf/thigh, Alternating Leg Pressure (ALP), Athrombic pumpscalf/thigh, on September 29, 2021 by guest. Protected copyright. 41 Continuous Enhanced Circulation Therapy (CECT), DVT bootscalf/thigh, EPC cuffs/ 42 stockingsExternal pneumatic compressioncalf/thigh, Flotron/Flotron DVT systemthigh, 43 Impulse pumpthigh, Intermittent pneumatic compression stockings, Intermittent 44 compression device (ICD), KCI stockings 45 5. Factor Xa Inhibitor 46 6. Direct thrombin inhibitor 47 7. Venous foot pumps (VFP): nAE pumpsfoot only, AV impulse system ,Foot pump, 48 Kendall AV impulse (foot), Kendall boots, Plantar venous plexus pumpfoot only, 49 Plexibootsfoot only, Pneumobootsfoot only, SC bootsfoot only, SCD bootsfoot only , 50 Venous foot pump 51 8. Other alternative anticoagulant 52 Please note: Anticoagulants at full therapeutic doses (full dose LMW heparin, Unfractionated 53 heparin IV, or warfarin) are considered acceptable treatment options for DVT prophylaxis. 54  DVT prevention doses may include: 55 ° dalteparin (Fragmin): 2500 or 5000 units SQ every day 56 57 58 59 39 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 65 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 ° enoxaparin (Lovenox): 3040 mg SQ every day or 2 times a day 4 ° fondaparinux (Arixtra): 2.5 mg SQ every day 5 ° Heparin: 5000 units SQ every 812 hrs 6 ° rivaroxaban (Xarelto) Oral: 10 mg every day for prevention of DVT after hip 7 surgery 8  Therapeutic doses, that may prevent DVT and also be effective as therapeutic 9 anticoagulation, may include: 10 ° apixaban (Eliquis): 5mg twice daily (2.5 mg twice daily in patients with two or more 11 of the following: age >/= 80 years, weight /= 1.5mg/dL) 12 ° argatroban at any dose IV infusion 13 14 ° dabigatran (Pradaxa): 150 mg 2 times a day (75 mg 2 times a day in patients with 15 renal failure) 16 ° dalteparinFor (Fragmin) peer : 100 mg/kg review SQ every 12hrs only 17 ° desirudin (Iprivask): 15 mg every 12 hoursenoxaparin (Lovenox): 1 mg/kg SQ 2 18 times a day 19 ° fondaparinux (Arixtra): 510 mg SQ every day 20 ° Heparin: continuous IV infusion titrated to elevated PTT outside the normal range. 21 Typical ranges could include PTT 5070 or 6084. 22 ° lepirudin (Refludan) at any dose IV infusion 23 ° rivaroxaban (Xarelto) Oral: 20 mg every day (15 mg every day in patients with 24 renal failure) 25  These doses are provided to aid in chart abstraction and are not an endorsement of 26 any of the specific medicines for the prevention of DVT. 27 Notes for Abstraction: 28 29 30  Select "Yes" if any of the above medications or treatments are ordered for the patient and initiated even if "DVT Prophylaxis" as the indication is not specifically 31 documented in physician orders or progress notes. Therapeutic anticoagulation also 32 meets the criteria for prophylaxis. Also, select "Yes" if a patient continues to receive http://bmjopen.bmj.com/ 33 one of the DVT prophylaxis listed above that was started prior to admission. 34  Select "No/Not Documented" if none of the above methods are ordered and 35 initiated for the patient. 36  To compute end of Hospital Day two, count the day of Arrival as hospital day one. 37 38  Reasons for not prescribing DVT prophylaxis must be documented by a physician. If reasons are not mentioned in the context of DVT prophylaxis, do not make 39 inferences. Patients with an inferior vena cava filter and DVT present prior to 40 admission may be inappropriate for DVT prophylaxis, if this is documented, select on September 29, 2021 by guest. Protected copyright. 41 "Contraindicated". 42  If documentation indicates that patient/caregiver refused DVT prophylaxis, choose 43 "Contraindicated". 44 Examples: 45 46  Patient 240a arrives at ED on Monday at 05:00. Because beds are full, patient 47 waits in ED holding bed, and patient is not delivered to the CCU until 15:00 Tuesday. 48  Hospital Day 1 is Monday (day of arrival at hospital), and hospital day 2 is Tuesday. 49 Patient should receive DVT prophylaxis by 23:59 on Tuesday in order to answer 50 "Yes". 51 Physician orders, Discharge records, Progress notes 52 53 Source of definition: GWTGHF 54 55 56 57 58 59 40 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 66 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 OPTIONAL: If yes, DVT Therapy: 4 5 Indicate medication and/or devices ordered and initiated by the end of hospital day two for 6 prophylaxis against the formation of deep venous thrombosis. 7  Low dose unfractionated heparin (LDUH) 8 9  Low molecular weight heparin (LMWH) 10  Intermittent pneumatic compression devices (IPC) 11  Factor Xa Inhibitor 12  Warfarin 13  Direct thrombin inhibitor 14  Venous foot pumps (VFP) 15 16  OtherFor peer review only 17 Physician orders, Discharge records, Progress notes 18 Source of definition: GWTGHF 19 20 INHOSPITAL COMPLICATIONS 21 22 OPTIONAL: DVT or PE 23 OPTIONAL: Myocardial Infarction 24 OPTIONAL: Cardiogenic shock OPTIONAL: Ischemic stroke 25 OPTIONAL: Hemorrhagic stroke 26 OPTIONAL: Bleeding 27 28 OPTIONAL: DVT or PE 29 30 31 Indicate if evidence of DVT or PE was documented in the medical record. This question refers to the inhospital development of DVT or PE. Preexisting DVT or PE prior to 32 http://bmjopen.bmj.com/ 33 admission should not be counted. 34  Yes 35  No/ND 36 37 The documentation of DVT or PE must be confirmed by ultrasound, venous imaging or 38 appropriate diagnostic modality. [The Joint Commission defines this as objectively confirmed 39 DVT based on duplex ultrasound, contrast venography, CT with contrast or CT venogram, MR imaging or MR venography]. Insure that the report clearly indicates that a deep vein, and

40 on September 29, 2021 by guest. Protected copyright. not a superficial vein, is involved. 41 42 Examples: 43 44  Patient 250a was prescribed DVT prophylaxis on admission to hospital for heart 45 failure. On day 4 of admission the patient had a tender calf, ultrasound revealed a 46 DVT of the left calf. Answer would be "Yes". 47  Patient 250b was prescribed DVT prophylaxis on admission to hospital for heart failure. On day 4 of admission the patient had a tender calf, ultrasound was negative 48 for DVT. Answer would be "No/ND". 49  Patient 250c was prescribed DVT prophylaxis on admission to hospital for heart 50 failure. On the day of admission, the patient complained of a tender calf for the 51 previous 3 days. Ultrasound revealed a DVT of the left calf. Answer would be "No/ND". 52  Patient 250d was prescribed DVT prophylaxis on admission to hospital for heart 53 failure. There is no documentation about imaging studies performed to identify DVT. 54 Answer would be "No/ND". 55 Physician orders, Discharge records, Progress notes 56 Source of definition: GWTGHF 57 58 59 41 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 67 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 OPTIONAL: Myocardial Infarction 4 5 Indicate if there is physician documentation of myocardial infarction during hospitalization 6 7 A myocardial infarction is evidenced by any of the following: 8 1. A rise and fall of cardiac biomarkers (preferably troponin) with at least one of the values in the abnormal range for that laboratory [typically above the 99th percentile of the upper 9 reference limit (URL) for normal subjects] together with at least one of the following 10 manifestations of myocardial ischemia: 11 a. Ischemic symptoms. 12 b. ECG changes indicative of new ischemia (new STT changes, new left bundle 13 branch block, or loss of R wave voltage). 14 c. Development of pathological Q waves in 2 or more contiguous leads in the ECG (or 15 equivalent findings for true posterior MI). 16 d.For Imaging evidencepeer of new review loss of viable myocardium only or new regional wall motion 17 abnormality. e. Documentation in the medical record of the diagnosis of acute myocardial infarction 18 based on the cardiac biomarker pattern in the absence of any items enumerated in ad 19 due to conditions that may mask their appearance (e.g., perioperative infarct when 20 the patient cannot report ischemic symptoms; baseline left bundle branch block or 21 ventricular pacing). 22 2. Imaging evidence of a region with new loss of viable myocardium at rest in the absence of a 23 nonischemic cause. This can be manifest as: 24 a. Echocardiographic, CT, MR, ventriculographic or nuclear imaging evidence of left 25 ventricular thinning or scarring and failure to contract appropriately (i.e., hypokinesis, 26 akinesis, or dyskinesis). b. Fixed (nonreversible) perfusion defects on nuclear radioisotope imaging (e.g., MIBI, 27 thallium). 28 3. Medical record documentation of myocardial infarction. 29 Progress notes, Discharge records 30 31 Source of definition: Joint ESCACCAHAWHF 2007 Task Force Consensus Document "Universal Definition of Myocardial Infarction"; adapted from AHA Get with the Guidelines ACTION

32 http://bmjopen.bmj.com/ registry 33 34 OPTIONAL: Cardiogenic shock 35 36 37 Indicate if there is physician documentation of cardiogenic shock during hospitalization. 38 Cardiogenic shock is defined as a sustained (>30 minutes) episode of systolic blood 39 pressure <90 mm Hg, and/or cardiac index <2.2 L/min/m2 determined to be secondary to

40 cardiac dysfunction, and/or the requirement for parenteral inotropic or vasopressor agents or on September 29, 2021 by guest. Protected copyright. 41 mechanical support (e.g., IABP, extracorporeal circulation, ventricular assist devices) to 42 maintain blood pressure and cardiac index above those specified levels. 43 Progress notes, Discharge records 44 Source of definition: China PEACE 45 46 OPTIONAL: Ischemic stroke 47 48 49 Indicate if there are physician documentations of newonset ischemia stroke and 50 strokerelated symptoms during hospitalization. The strokerelated symptoms include: 51 trouble walking/loss of balance/incoordination, onesided numbness or hemianesthesia, 52 onesided facial numbness or hemianesthesia, mouth askew and drooling, dysarthria or slurred speech, loss of vision or blurred vision in one or both eyes, dizziness with vomiting, 53 severe headache and vomiting, unconsciousness, and hyperspasmia. 54 Progress notes, Discharge records 55 56 Source of definition: China PEACE 57 58 59 42 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 68 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 OPTIONAL: Hemorrhagic stroke 4 5 Indicate if there are physician documentations of newonset hemorrhagic stroke and 6 strokerelated symptoms during hospitalization. 7 Progress notes, Discharge records 8 9 Source of definition: China PEACE 10 11 OPTIONAL: Bleeding 12 13 Indicate if the patient had a bleeding event during hospitalization. 14 15 Bleeding is defined as documented bleeding event or drop in hemoglobin of≥3 g/dL 16 Progress notes,For Discharge peer records review only 17 18 Source of definition: China PEACE 19 20 21 INHOSPITAL OUTCOME 22 23 REQUIRED: Length of Stay 24 OPTIONAL: Death 25 26 REQUIRED: Length of Stay 27 28 29 Indicate the duration between date of admission and date of discharge in days（discharge date 30 minus admission date）. If the patient has ever stayed in an intensive care unit or cardiovascular 31 care unit, record the duration.

32 Front page, Discharge records, Temperature report http://bmjopen.bmj.com/ 33 34 Source of definition: China PEACE 35 OPTIONAL: Death 36 37 38 Indicate if the patient died between arrival at this facility and discharge. 39 If yes, record the date/time of death.

40 If yes, select one of the following options as primary cause of death: on September 29, 2021 by guest. Protected copyright. 41 ° Acute coronary syndrome 42 ° Worsening heart failure 43 ° Sudden death 44 ° Hemorrhagic stroke 45 ° Ischemic stroke 46 ° Pulmonary embolism 47 ° Other documented reason 48 ° Unknown 49 Front page, Discharge records, Progress notes 50 Source of definition: China PEACE 51 52 53 54 DISCHARGE INFORMATION 55 56 REQUIRED: Discharge Date and time 57 58 59 43 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 69 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 OPTIONAL: Inhospital Expense 4 OPTIONAL: Get With The Guidelines® HF Mortality Risk Score 5 REQUIRED: What was the patient’s discharge disposition on the day of discharge? OPTIONAL: Symptoms (Closest to Discharge) 6 OPTIONAL: Vital Signs (Closest to Discharge) 7 OPTIONAL: Exam (Closest to Discharge) 8 OPTIONAL: Labs (Closest to Discharge) 9 10 REQUIRED: Discharge Date and time 11 12 13 Record the month, day, and year the patient was discharged from acute care, left against medical advice, or expired during this stay. Use the format YYYY/MM/DD. 14 15 Record the time that the patient was discharged, left against medical advice or expired 16 during this stay.For Use military peer time: HH:MM. review only 17 Front page, Discharge records, Temperature report 18 Source of definition: GWTGHF 19 20 OPTIONAL: Inhospital Expense 21 22 23 Record the total Inhospital Expense, and the expense on western medicine, traditional Chinese medicine (TCM), and surgery if available. 24 25 Front page 26 Source of definition: China PEACE 27 28 OPTIONAL: Get With The Guidelines® HF Mortality Risk Score 29 30 Calculation of predicted probability of inhospital death based on heart failure patient risk 31 factors present on admission. This risk score represents the individual patient’s predicted

32 risk for inhospital mortality. It is reported as a percentage. It is calculated based on 5 http://bmjopen.bmj.com/ 33 variables at time of hospital presentation: age, BUN, systolic blood pressure, heart rate, and 34 serum sodium. This risk score formula was derived and validated using the Get With The 35 Guidelines®HF database. This risk prediction is intended to enhance not replace clinical 36 assessment and physician judgment. If one or more of the 5 variables are missing the risk 37 score cannot be calculated for the patient. 38 39

40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 44 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 70 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 For peer review only 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

32 http://bmjopen.bmj.com/ 33 34 35 36 Source of definition: GWTGHF 37 38 REQUIRED: What was the patient’s discharge disposition on the day of discharge? 39

40 on September 29, 2021 by guest. Protected copyright. 41 Definition: The final place or setting to which the patient was discharged on the day of discharge. 42 Allowable Values: 43 1. Home 44 2. Other hospital (higher level) 45 3. Other hospital (lower level) 46 4. Left Against Medical Advice/AMA 47 5. Treatment withdrawal: Indicate if the patient withdrew from treatments with 48 worsening condition 49 Discharge records 50 Source of definition: China PEACE 51 52 OPTIONAL: Symptoms (Closest to Discharge) 53 54 55 Select the term that best describes symptoms present closest to the time of discharge or death compared to those closest to admission: 56 ° Worse: Documentation indicates that the patient's symptoms have worsened 57 58 59 45 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 71 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 compared to the patient's symptoms at admission. 4 ° Unchanged: Documentation indicates that the patient's symptoms are unchanged 5 compared to the patient's symptoms at admission. 6 ° Better, symptomatic: Documentation indicates that the patient's symptoms have improved compared to the patient's symptoms at admission, but the patient continues to have some 7 symptoms of heart failure. 8 ° Better, asymptomatic: Documentation indicates that the patient's symptoms have 9 improved compared to the patient's symptoms at admission and the patient is 10 asymptomatic. 11 ° Unable to determine: Insufficient documentation to determine the status of the 12 patient's symptoms at discharge compared to the patient's symptoms at admission. 13 Front page, Discharge records, Progress notes 14 Source of definition: GWTGHF 15 16 OPTIONAL: VitalFor Signs (Closest peer to Discharge) review only 17 18 19 Record vital signs and weight closest to the time of discharge or death. 20 ° Weight: Even if weight was taken prior to discharge, that value can be entered here. 21 However, if weight recorded closest to discharge is the admission weight, it should not be 22 captured here. In that case, you should use the Not Well Documented check box. 23 ° Heart Rate (required): in beats/minute ° BP (required): in mm/Hg (systolic/diastolic) 24 ° Note: Blood pressure can be recorded in VAD patients use the available recorded 25 value. 26 27 Discharge records, Progress notes, Temperature report 28 Source of definition: GWTGHF 29 30 OPTIONAL: Exam (Closest to Discharge) 31

32 Record the physical findings closest to discharge or death. http://bmjopen.bmj.com/ 33 ° The third heart sound: Select Yes, No or Unknown. 34 ° Jugular vein distension: Select Yes, No or Unknown. 35 ° Hepatojugular reflux: Select Yes, No or Unknown. 36 ° Rales: Select Yes or No. If Yes, select greater than or equal to 1/3, <1/3 or N/A. 37 ° Lower Extremity Edema: Select Yes or No. 38 Discharge records, Progress notes 39 Source of definition: China PEACE

40 on September 29, 2021 by guest. Protected copyright. 41 OPTIONAL: Labs (Closest to Discharge) 42 43 44 Enter the lab values for Na, BNP, SCr, BUN, NTBNP, and K. These labs are based on 45 results obtained closest to the time of discharge. 46 ° Na: indicate whether the value is in mEq/L, mmol/L or mg/dL. 47 ° BNP: indicate whether the value is in pg/mL, pmol/l or ng/L. 48 ° SCr: indicate whether the value is in mg/dL or mol/L. 49 ° BUN: Indicated in mg/dL or mol/L BNP or NTBNP: Btype naturetic peptide (BNP) or Nterminal BNP (NTBNP) blood 50 test levels in pg/mL. Elevated BNP have been associated with heart failure, elevated 51 LV filling pressures, acute MI and ischemia. Elevated levels tend to support 52 abnormal left ventricular function and hemodynamics and provide prognostic 53 information. 54 ° NTBNP: indicate the value in pg/mL. 55 ° K: indicate whether the value is in mEq/L, mmol/L, or mg/dL. 56 Discharge records, Progress notes, Lab test 57 58 59 46 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 72 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 Source of definition: GWTGHF 4 5 6 7 DISCHARGE MEDICATIONS 8 9 10 REQUIRED: ACEI/ARB Prescribed at Discharge REQUIRED: BetaBlocker Prescribed at Discharge 11 REQUIRED: Aldosterone Antagonist Prescribed at Discharge 12 REQUIRED: Anticoagulation Therapy Prescribed at Discharge 13 OPTIONAL: Aspirin Prescribed at Discharge 14 OPTIONAL: Clopidogrel Prescribed at Discharge 15 OPTIONAL: Other Antiplatelet Prescribed at Discharge 16 REQUIRED: ForHydralazine peer Nitrate Prescribed review at Discharge only 17 OPTIONAL: Diabetic Tx at Discharge 18 OPTIONAL: Lipid Lowering Medications at Discharge 19 OPTIONAL: Other Medications at Discharge 20 21 REQUIRED: ACEI/ARB Prescribed at Discharge 22 23 Documentation that angiotensin converting enzyme inhibitor (ACEI) was prescribed at hospital 24 discharge. 25  Select Yes if ACE Inhibitors are prescribed at discharge 26  Select No if ACE Inhibitors are not prescribed at discharge, OR if this information 27 cannot be determined from the medical record 28 Notes for Abstraction: 29 30  In determining whether an ACEI was prescribed at discharge, it is not uncommon 31 to see conflicting documentation amongst different medical record sources. For example, the discharge summary may list an ACEI that is not included in any of the

32 http://bmjopen.bmj.com/ other discharge medication sources (e.g., discharge orders). All discharge medication 33 documentation available in the chart should be reviewed and taken into account by the 34 abstractor. 35 ° In cases where there is an ACEI in one source that is not mentioned in other 36 sources, it should be interpreted as a discharge medication (select "Yes") 37 unless documentation elsewhere in the medical record suggests that it was 38 NOT prescribed at discharge Consider it a discharge medication in the 39 absence of contradictory documentation. If documentation is contradictory

40 (e.g., physician noted “d/c Zestril” in the discharge orders, but Zestril is listed in on September 29, 2021 by guest. Protected copyright. 41 the discharge summary's discharge medication list), or after careful examination 42 of circumstances, context, timing, etc, documentation raises enough questions, the case should be deemed "unable to determine" (select "No”). 43 ° Consider documentation of a hold on an ACEI after discharge in one location 44 and a listing of that ACEI as a discharge medication in another location as 45 contradictory ONLY if the timeframe on the hold is not defined (e.g., “Hold 46 Zestril”). Examples of a hold with a defined timeframe include “Hold captopril x2 47 days” and “Hold Quinaretic until after stress test.” If an ACEI is NOT listed as a 48 discharge medication, and there is only documentation of a hold or plan to delay 49 initiation/restarting of an ACEI after discharge (e.g., “Hold captopril x2 days,” 50 “Start ACEI as outpatient,” “Hold Zestril”), select “No”. 51 ° If two discharge summaries are included in the medical record, use the one with 52 the latest date/time. If one or both are not dated or timed, and you cannot 53 determine which was done last, use both. This also applies to discharge 54 medication reconciliation forms. Use the dictated date/time over transcribed date/time, file date/time, etc. 55 56 Examples: 57 58 59 47 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 73 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3  Two discharge summaries, one dictated 5/22 (day of discharge) and one 4 dictated 5/27 Use the 5/27 discharge summary. 5  Two discharge medication reconciliation forms, one not dated and one 6 dated 4/24 (day of discharge) Use both. 7 ° Disregard an ACEI medication documented only as a recommended medication 8 for discharge (e.g., “Recommend sending patient home on Vasotec”). Documentation must be more clear in stating that the ACEI was actually 9 prescribed at discharge. 10 ° Disregard documentation of ACEI prescribed at discharge when noted only by 11 medication class (e.g., “ACEI Prescribed at Discharge: Yes” on a core 12 measures form). The ACEI must be listed by name. 13 Discharge records, Physician orders 14 15 Source of definition: GWTGHF 16 OPTIONAL: ACEI/For ARB: Dose/Frequency peer review only 17 18 19 Select the specific ACEI/ ARB Medication that was prescribed at discharge. Enter the dosage and 20 frequency (optional). Frequency abbreviations include: 21  QD: every day 22  BID: twice a day 23  TID: 3 times a day 24  QID: 4 times a day 25 Discharge records, Physician orders 26 Source of definition: GWTGHF 27 28 REQUIRED: ACEI Contraindicated and ARB Contraindicated at Discharge? 29 30 31 ACEIs and ARBs widen or dilate blood vessels, lowering blood pressure and making it easier for the heart to pump blood. They also inhibit the adverse effects of neurohormonal activation on the

32 http://bmjopen.bmj.com/ heart. These effects help reduce the risk of adverse outcomes such as death or hospitalization. 33 34 Allowable Values: 35 36  Yes: There is documentation of BOTH a reason for not prescribing an ACEI at 37 discharge AND a reason for not prescribing an ARB at discharge. 38  No: There is no documentation of BOTH a reason for not prescribing an ACEI at 39 discharge AND a reason for not prescribing an ARB at discharge, or unable to

40 determine from medical record documentation. on September 29, 2021 by guest. Protected copyright. 41 Notes for Abstraction: 42 43  An “allergy” or “sensitivity” documented at any time during the hospital stay counts as an allergy regardless of what type of reaction might be noted (e.g., “Allergies: 44 ACEIs – Cough” – consider as ACEI allergy). 45  Documentation of an allergy/sensitivity to one particular ACEI is acceptable to take 46 as an allergy to the entire class of ACEIs. Same for ARBs (e.g., “Allergic to Valsartan” 47 consider as ARB allergy). 48  When conflicting information is documented in a medical record, select “Yes”. 49  In the absence of explicit documentation that the patient has current 50 moderate/severe aortic stenosis, this should be inferred when there is documentation 51 of a history of moderate/severe aortic stenosis without mention of repair or 52 replacement, valvuloplasty, or commissurotomy. 53  When determining whether there is a reason documented by a physician for not 54 prescribing an ACEI or an ARB at discharge: 55  Documentation of a reason for not prescribing one class (either ACEI or ARB) 56 should be considered implicit documentation of a reason for not prescribing the 57 58 59 48 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 74 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 other class for the following five conditions ONLY: 4  Angioedema 5  Hyperkalemia 6  Hypotension 7  Renal artery stenosis 8  Worsening renal function/renal disease/dysfunction 9  Examples of statements that count as a reason for not prescribing ACEI and a 10 reason for not prescribing ARB at discharge: 11  “Creatinine high. Hold losartan.” 12  “Hx angioedema with ACEIs.” 13  “No ACEI. Bilateral renal artery stenosis.” 14  “BPs running low. Discontinue losartan.” 15  “Potassium 5.5 – No ACEI.” “ 16 For Severe peer hypotension reviewwith ACEIs in past.” only 17  “Add ARB if hyperkalemia resolves.” 18  Reasons for no ACEIs and reasons for no ARBs must be explicitly documented (e.g., “Potassium 5.5 – No ACEI”) or clearly implied (e.g., “Severe 19 hypotension with ACEIs in past,” “Hx ACEIinduced cough,” “ARBs 20 contraindicated,” “Pt. refusing all medications,” “Supportive care only – no 21 medications,” “ACEI therapy not indicated,” ACEI on preprinted order form is 22 crossed out, “No ACEI/ARB” [reason not given]). If reasons are not mentioned in 23 the context of ACEIs/ARBs, do not make inferences (e.g., Do not assume that an 24 ACEI/ARB is not prescribed because of the patient's chronic renal disease 25 alone). 26  Physician documentation of a hold on an ACEI or discontinuation of an ACEI 27 that occurs during the hospital stay constitutes a “clearly implied” reason for not 28 prescribing an ACEI at discharge. A hold/discontinuation of all p.o. medications counts if an ACEI p.o. was on order at the time of the notation. Same for ARBs. 29 EXCEPTIONS: 30 31  Documentation of a conditional hold/discontinuation of an ACEI /ARB

32 does not count as a reason for not prescribing an ACEI /ARB at discharge http://bmjopen.bmj.com/ 33 UNLESS (1) it exists as an order to hold/discontinue the ACEI/ARB if the 34 blood pressure (BP) falls outside certain parameters, AND (2) the ACEI/ARB 35 was held due to a BP outside the parameters. Nursing documentation is 36 acceptable. E.g., “Hold perindopril for SBP less than 100” ordered and the 37 nurse documents that the perindopril was held for a BP of 90/50 – select 38 “Yes.” 39  Discontinuation of a particular ACEI medication documented in combination with the start of a different ACEI medication (i.e., switch in type 40 of ACEI medication) does not count as a reason for not prescribing an ACEI on September 29, 2021 by guest. Protected copyright. 41 at discharge. Same for ARBs. 42  Examples: 43  “Stop benazepril” and “Start captopril 50 mg po bid” in the same 44 physician order 45  “Change Diovan to Verdia” in progress note 46  “Do not continue after discharge” checked for Lotensin and 47 “Continue after discharge” checked for Zestril on a physiciansigned 48 discharge medication reconciliation form 49  Discontinuation of an ACEI medication at a particular dose documented 50 in combination with the start of a different dose of that ACEI (i.e., change in 51 dosage) does not count as a reason for not prescribing an ACEI at 52 discharge. Same for ARBs. Documentation of reasons which refer to a more 53 general medication class are not acceptable (e.g., “Hold all BP meds”). 54  Examples: 55  “Stop lisinopril 20 mg po q am” and “Start lisinopril 30 mg po q am” in 56 same physician order 57 58 59 49 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 75 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3  “Increase Altace 5 mg to 10 mg” in progress note 4  “Do not continue after discharge” check for Cozaar 25 mg and 5 “Continue after discharge” checked for Cozaar 50 mg on a 6 physiciansigned discharge medication reconciliation form

7  Deferral of an ACEI from one physician to another does NOT count as a 8 reason for not prescribing an ACEI at discharge unless the problem underlying 9 the deferral is also noted. Same for ARBs. 10  Examples: 11  “Consulting cardiologist to evaluate pt. for ACEI therapy” select 12 “No” (Do NOT consider as reason for not prescribing ACEI at 13 discharge). 14  “Pt. hypotensive. Start ARB if OK with cardiology.” select "Yes" 15 (Consider as reason for not prescribing ACEI and reason for not 16 Forprescribing peer ARB at discharge).review only 17  If there is documentation of a plan to initiate/restart an ACEI, and the 18 reason/problem underlying the delay in starting/restarting the ACEI is also noted, 19 this constitutes a “clearly implied” reason for not prescribing ACEI at discharge. 20 Same for ARBs. 21 Acceptable examples (select “Yes”): 22 23  "Pt. hemodynamically unstable. May start ACEI/ARB as outpatient.” 24  “Add ARB if hyperkalemia resolves” Unacceptable examples (select “No”): 25 26  “Consider starting Cozaar in a.m.” (Do NOT consider as reason for 27 not prescribing ARB at discharge) 28  “May add accupril when pt. can tolerate” (Do NOT consider as 29 reason for not prescribing ACEI at discharge) 30  Reasons do NOT need to be documented at discharge or otherwise linked to 31 the discharge timeframe: Documentation of reasons anytime during the hospital

32 stay are acceptable (e.g., midhospitalization note stating “no ACEIs due to acute http://bmjopen.bmj.com/ 33 renal failure” consider as reason for not prescribing ACEI and reason for not 34 prescribing ARB at discharge, even if documentation indicates that the acute 35 renal failure had resolved by the time of discharge and ACEI was restarted). 36  Crossing out of an ACEI counts as a " clearly implied reason" for not 37 prescribing an ACEI at discharge only if on a preprinted form. Same for ARBs. 38  ACEIs/ARBs are sometimes described as RAS (reninangiotensin system) or RAAS (reninangiotensinaldosterone system) blockers/inhibitors. Documentation 39 of a reason for not prescribing "RAS" or "RAAS" blockers or inhibitors should be 40 considered implicit documentation of a reason for no ACEI and no ARB at on September 29, 2021 by guest. Protected copyright. 41 discharge (e.g., "Hold all RAS blockers"). 42  When the current record includes documentation of a prearrival reason for no 43 ACEI or no ARB, the following counts regardless of whether this documentation is 44 included in a prearrival record as part of the current record or whether it is noted by 45 hospital staff during the current hospital stay: 46  Prearrival ACEI allergy (reason for not prescribing ACEI) or ARB allergy 47 (reason for not prescribing ARB). 48  Prearrival moderate/severe aortic stenosis (reason for not prescribing an 49 ACEI and a reason for not prescribing an ARB). 50  Prearrival hold/discontinuation of an ACEI or notation such as "No ACEIs" IF 51 the underlying reason/problem is also noted (e.g., “ Prinivil held in transferring 52 hospital due to hypotension”). Same for ARBs. 53  Prearrival "other reason" (other than hold/discontinuation or notation of "No 54 ACEIs") (e.g., "Hx severe hypotension with enalapril" in transferring ED record). 55 Same for ARBs. 56 Guidelines for Abstraction: 57 58 59 50 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 76 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 Inclusion Exclusion

4 Angioedema ACEI Allergy 5 6  Angioneurotic edema  ACEI allergy described using 7  Edema of the eyelid, glottis, larynx, nasopharynx, or pharynx the negative modifiers or qualifiers ARB Allergy 8  Periorbital edema described as acute 9 Hyperkalemia  ARB allergy described using 10 the negative modifiers or qualifiers 11  Patient's potassium (K+) level noted (e.g., "Last Potassium 6.5. Will Moderate/severe aortic stenosis (AS)

12 hold off on ACEI therapy")  Potassium (K+) level described as elevated 13  aortic insufficiency only  References to potassium not specified or described as hyperkalemia  aortic regurgitation only 14 (e.g., “Hold off on ACEI therapy. Check potassium.”, “Start candesartan once 15 potassium improved”)  aortic stenosis described as 16 Hypotension 1+ or 2+ Moderate/severe aortic For peer review onlystenosis, or any of the other 17 moderate/severe aortic stenosis  Blood pressure (BP) described as low 18 inclusion terms, described the  Patient's blood pressure (BP) measurement noted (e.g., "BP systolic negative modifiers or qualifiers 19 running in 80s. Will not prescribe ARBs at this time") 20  References to blood pressure not specified or described as hypotension 21 (e.g., “Hold off on ACEI therapy. Check BP in a.m.”, “Start candesartan after 22 BP normalizes”) 23  Shock Moderate/severe aortic stenosis (AS) 24 25  Aortic stenosis described as 3+, 4+, critical, or significant 26  Aortic stenosis, degree of severity not specified 27  Aortic valve area of less than 1.0 square cms 28  Subaortic stenosis, moderate/severe or degree of severity not specified 29 Worsening renal function/renal disease/dysfunction 30 31  Acute kidney injury (AKI)

32  Azotemia http://bmjopen.bmj.com/ 33  Chronic kidney disease (CKD) 34  Dialysis 35  End stage renal disease (ESRD) 36  Nephritis 37  References to creatinine not specified or described as elevated (e.g., “Hold off on ACEI therapy. Check creatinine.”, “Start candesartan once 38 creatinine improved”) 39  References to renal/renal function not specified or described as renal

40 dysfunction (e.g., “Hold on ACEI pending kidney function panel in a.m.”, “Start on September 29, 2021 by guest. Protected copyright. 41 candesartan after nephrology sees”) 42  Renal failure, acute or chronic (ARF, RF, CRF) 43  Renal insufficiency (RI, CRI) 44  Renal/kidney transplant (RT, RTx, s/p renal transplant, KT) 45  Serum creatinine (Cr, Cre) level described as abnormal or elevated 46  Serum creatinine (Cr, Cre) noted (e.g., "No ACEIs. Creatinine 2.0") 47 Discharge records, Progress notes 48 Source of definition: GWTGHF 49 50 OPTIONAL: Contraindications or other documented reason(s) for not providing ACEI or ARB: 51 52 Select all options that apply as to why the patient was not provided ACEI or ARB: 53 54  Pregnancy 55  Allergy 56  Hyperkalemia: serum potassium >55 mmol/L 57 58 59 51 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 77 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3  Moderatesevere aortic stenosis 4  Renal dysfunction 5  Hypotension: SBP<90mmHg or DB<60mmHg 6  Bilateral renal artery stenosis 7  Breast feeding 8 Discharge records, Progress notes 9 Source of definition: China PEACE 10 11 REQUIRED: BetaBlocker Prescribed at discharge 12 13 Betablocker was prescribed at discharge. 14 15  Yes: A betablocker medication was prescribed at discharge 16  No:For A betablocker peer medication review was not prescribed atonly discharge, OR this 17 information cannot be determined from the medical record 18 19 Notes for Abstraction: 20 21  In determining whether a betablocker was prescribed at discharge, it is not uncommon to see conflicting documentation amongst different medical record 22 sources. For example, the discharge summary may list a betablocker that is not 23 included in any of the other discharge medication sources (e.g., discharge orders). All 24 discharge medication documentation available in the chart should be reviewed and 25 taken into account by the abstractor. 26  In cases where there is a betablocker in one source that is not mentioned in other 27 sources, it should be interpreted as a discharge medication (select "Yes") unless 28 documentation elsewhere in the medical record suggests that it was NOT prescribed 29 at discharge Consider it a discharge medication in the absence of contradictory 30 documentation. 31  If documentation is contradictory (e.g., physician noted “d/c Coreg” in the discharge orders, but Coreg is listed in the discharge summary's discharge medication list), or

32 http://bmjopen.bmj.com/ after careful examination of circumstances, context, timing, etc., documentation raises 33 enough questions, the case should be deemed "unable to determine" (select "No"). 34  Consider documentation of a hold on a betablocker after discharge in one location 35 and a listing of that betablocker as a discharge medication in another location as 36 contradictory ONLY if the timeframe on the hold is not defined (e.g., “Hold Coreg”). 37 Examples of a hold with a defined timeframe include “Hold Lopressor x2 days” and 38 “Hold Propranolol until after stress test.” 39  If a betablocker is NOT listed as a discharge medication, and there is only documentation of a hold or plan to delay initiation/restarting of a betablocker after 40 on September 29, 2021 by guest. Protected copyright. 41 discharge (e.g., “Hold Lopressor x2 days,” “Start betablocker as outpatient,” “Hold 42 Coreg”), select “No”. 43  If two discharge summaries are included in the medical record, use the one with the latest date/time. If one or both are not dated or timed, and you cannot determine which 44 was done last, use both. This also applies to discharge medication reconciliation 45 forms. Use the dictated date/time over transcribed date/time, file date/time, etc. 46  Disregard a betablocker medication documented only as a recommended 47 medication for discharge (e.g., “Recommend sending patient home on sotalol”). 48  Documentation must be more clear in stating that a betablocker was actually 49 prescribed at discharge. 50  Disregard documentation of betablocker prescribed at discharge when noted only 51 by medication class (e.g., “BetaBlocker Prescribed at Discharge: Yes” on a core 52 measures form). The betablocker must be listed by name. 53 Discharge records, Physician orders 54 Source of definition: GWTGHF 55 56 57 58 59 52 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 78 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 REQUIRED: If yes, Class of Beta Blocker 4 5 What was the class of beta blocker prescribed at hospital discharge? 6 7  EvidenceBased Beta Blocker: Select “EvidenceBased Beta Blocker” if the 8 patient was discharged on one of the three beta blocker medications classified as 9 evidencebased in the AHA/ACCF Heart Failure Guidelines. Evidencebased beta blockers include ONLY the following medications: Bisoprolol, Carvedilol and 10 Metoprolol Succinate CR/XL. These medications may have generic or brand name 11 equivalents. Below is an exhaustive list of evidencebased beta blockers. Only 12 select “EvidenceBased Beta Blocker” if the patient is discharged on one of these 13 medications. 14 ° EvidenceBased Beta Blockers 15  Bisoprolol (includes the following): 16 For Bisoprolol peer review only 17  Bisoprolol fumerate 18  Bisoprolol/Hydrochlorothiazide 19  Zebeta 20  Ziac 21  Coreg (Carvedilol) (includes the following): 22  Carvedilol 23  Carvedilol CR 24  Coreg 25  Coreg CR 26  Toprol XL (Metoprolol succinate CR/XL) (includes the following): 27  Dutoprol 28  Metoprolol succinate 29  Metoprolol succinate CR/XL 30  Metoprolol succinate CR/XL/hydrochlorothiazide 31  Toprol  Toprol XL 32 http://bmjopen.bmj.com/ 33  NonEvidenceBased Beta Blocker: Select “NonEvidenceBased Beta Blocker” if the patient was discharged with a prescription for a beta blocker that is not 34 evidencebased. Select this option for any beta blocker prescribed at discharge that 35 is not on the above list of EvidenceBased Beta Blockers. 36  Unknown Class: Select this if you cannot determine from the medical record 37 documentation whether the beta blocker prescribed at discharge was 38 evidencebased or nonevidencebased. 39

40 Notes for Abstraction: on September 29, 2021 by guest. Protected copyright. 41 42 ° The 2013 ACCF/AHA Guideline for the Management of Patients with Heart 43 Failure 44 (http://circ.ahajournals.org/content/early/2013/06/03/CIR.0b013e31829e8776) 45 reaffirmed the 2009 guideline, which recommended using 1 of the 3 beta 46 blockers proven to reduce mortality ( bisoprolol, carvedilol, and sustained 47 release metoprolol succinate) for all stable patients with current or prior 48 symptoms of HF and reduced LVEF, unless contraindicated (Level of Class 1 49 Level of Evidence: A). 50 ° This question seeks to determine the class of beta blocker prescribed at hospital discharge. Class should ONLY be determined by referencing the 51 specific prescribed beta blocker medication at hospital discharge. 52 ° The selection of “EvidenceBased Beta Blocker” for beta blocker class must 53 align with your response to the subsequent element, “If yes, medication”. If 54 these responses are not reconciled, you will not be able to save your record as 55 complete. The three appropriate medication responses correlating to 56 evidencebased beta blocker are: 57 58 59 53 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 79 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3  Bisoprolol 4  Coreg (Carvedilol) 5  Toprol XL (Metoprolol succinate CR/XL) 6 ° The selection of “NonEvidenceBased Beta Blocker” for beta blocker class 7 should align with your response to the subsequent element, "If yes, medication". The appropriate medication responses correlating to nonevidencebased beta 8 blocker are: Blocadren (Timolol maleate) 9  Inderal (Propanolol HCl) 10  Kerlone (Betaxolol HCl) 11  Levatol (Penbutolol sulfate) 12  Lopressor (Metoprolol) 13  Sectral (Acebutolol HCl) 14  Tenormin (Atenolol) 15  Visken (Pindolol) 16 ° ForIf you select peer “Unknown Class” review for beta blocker class,only this should align with your 17 response to the subsequent element “If yes, medication. The appropriate 18 medication responses correlating to evidenced Unknown Class are: 19  Other 20 21 If Yes, (Specify) 22 23 24 REQUIRED: Medication 25 26 Select from the list the specific betablocker that was prescribed. 27 28 OPTIONAL: Beta Blocker: Dosage, Frequency 29 30 31 Enter the dosage and frequency (optional). Frequency options include:

32  Every day http://bmjopen.bmj.com/ 33  2 times a day 34  3 times a day 35  4 times a day 36 Discharge records, Physician orders 37 Source of definition: GWTGHF 38 39 REQUIRED: Beta Blocker Contraindicated at discharge?

40 on September 29, 2021 by guest. Protected copyright. 41 42 Documentation of reasons for not prescribing a betablocker at discharge. 43  Yes: There is documentation of a reason for not prescribing a betablocker at 44 discharge. 45  No: There is no documentation of a reason for not prescribing a betablocker at 46 discharge or unable to determine from medical record documentation. 47 48 Notes for Abstraction: 49 50  A betablocker “allergy” or “sensitivity” documented at any time during the hospital 51 stay counts as an allergy regardless of what type of reaction might be noted (e.g., 52 “Allergies: Betablockers – Impotence” – select “Yes”). 53  Documentation of an allergy/sensitivity to one particular betablocker is acceptable 54 to take as an allergy to the entire class of betablockers (e.g., "Allergic to Lopressor"). 55  When conflicting information is documented in a medical record, select "Yes". 56  When determining whether there is second or thirddegree heart block on ECG on 57 58 59 54 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 80 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 arrival or during hospital stay AND does not have pacemaker: 4 ° Consider this true if (1) there are findings of second or thirddegree heart block 5 on the ECG AND this same ECG does NOT show pacemaker findings, OR (2) There is documentation of a finding of second or thirddegree heart block (not 6 specifically referenced as an ECG finding) without mentioning the presence of 7 pacemaker findings (e.g., "Seconddegree heart block" per ER report). 8 ° Disregard pacemaker findings if documentation suggests that the patient has a 9 nonfunctioning pacemaker 10 ° Second or thirddegree heart block and pacemaker ECG findings can be taken 11 from unsigned ECG reports. Physician order is not required. 12 ° Second or thirddegree heart block findings and pacemaker findings from 13 telemetry and rhythm strips are acceptable. 14 ° In cases where ECG findings of second or thirddegree heart block are 15 referenced and documentation does not address the presence or absence of 16 Forpacemaker peer findings, infer noreview pacemaker findings. only E.g., "ECG on arrival showed 17 seconddegree heart block" per H&P. 18  When determining whether there is a reason documented by a physician for not prescribing a betablocker at discharge: 19 ° Reasons must be explicitly documented (e.g., “COPD No BBs”, “HR running in 20 50s. Hold off on betablocker therapy” ) or clearly implied (e.g., “Severe 21 hypotension with betablockers in past,” “BBs contraindicated,” “Pt. refusing all 22 medications,” “Supportive care only – no medications,” “BBs not indicated,” 23 betablocker on preprinted order form is crossed out, “No betablockers” [no 24 reason given]). If reasons are not mentioned in the context of betablockers, do 25 not make inferences (e.g., Do not assume that a betablocker is not being 26 prescribed because of the patient's history of Peripheral Vascular Disease 27 alone). 28 ° Use of positive inotropic agent must be explicitly documented in the context of 29 betablockers in order to select "Yes" to "Beta Blocker Contraindicated". Do not make inferences that beta blocker is contraindicated because the patient is 30 receiving a positive inotropic medication 31 ° Physician documentation of a hold on a betablocker or discontinuation of a

32 betablocker that occurs during the hospital stay constitutes a “clearly implied” http://bmjopen.bmj.com/ 33 reason for not prescribing a betablocker at discharge. A hold/discontinuation of 34 all p.o. medications counts if betablocker p.o. was on order at the time of the 35 notation. 36 37 EXCEPTIONS: 38 39  Documentation of a conditional hold/discontinuation of a betablocker does

40 not count as a reason for not prescribing a betablocker at discharge on September 29, 2021 by guest. Protected copyright. 41  UNLESS (1) it exists as an order to hold/discontinue the betablocker if the 42 blood pressure (BP) or heart rate (HR) falls outside certain parameters, AND 43 (2) the betablocker was held due to a BP/HR outside the parameters. 44 Nursing documentation is acceptable. E.g., “Hold atenolol for SBP less than 45 100” ordered and the nurse documents that the atenolol was held for a BP of 90/50 – select “Yes.” 46  Discontinuation of a particular betablocker medication documented in 47 combination with the start of a different betablocker medication (i.e., switch 48 in type of betablocker medication) does not count as a reason for not 49 prescribing a betablocker at discharge. 50 Examples: 51  "Stop sotalol" and "Start Tenormin 50 mg po qd" in the same physician 52 order 53  "Change Lopressor to Coreg" in progress note 54  "Do not continue after discharge" checked for metoprolol and "Continue 55 after discharge" checked for Bystolic on a physiciansigned discharge 56 medication reconciliation form 57 58 59 55 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 81 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3  Discontinuation of a betablocker medication at a particular dose 4 documented in combination with the start of a different dose of that 5 betablocker (i.e., change in dosage) does not count as a reason for not prescribing a betablocker at discharge. Examples: 6  "Stop Inderal 40 mg po bid" and "Start Inderal 40 mg po tid" in same 7 physician order, "Increase Lopressor 50 mg to 100 mg" in progress note, 8  "Do not continue after discharge" checked for Coreg 3.125 mg and 9 "Continue after discharge" checked for Coreg 6.25 mg on a 10 physiciansigned discharge medication reconciliation form 11 ° Documented reasons referring to a more general medication class is not 12 acceptable (e.g., "Hold all BP meds"). 13 ° Documented reasons referring to eye drops containing betablocker is not 14 acceptable (e.g., "Dc Timolol drops"). 15 ° Deferral of a betablocker from one physician to another does NOT count as a 16 Forreason for notpeer prescribing areview betablocker at discharge only unless the problem 17 underlying the deferral is also noted. Examples: 18  "Consulting cardiologist to evaluate pt. for BB treatment" select "No." 19  "Pt. hypotensive. Start betablocker if OK with cardiology." select "Yes." 20 ° If there is documentation of a plan to initiate/restart a betablocker, and the reason/problem underlying the delay in starting/restarting the betablocker is 21 also noted, this constitutes a "clearly implied" reason for not prescribing a 22 betablocker at discharge. 23 Acceptable examples (select "Yes"): 24 "BPs running low. May start Atenolol as outpatient.” 25 “Add Toprol if HR stabilizes” 26 Unacceptable examples (select "No"): 27 28 “Consider starting Corgard in a.m.” 29 “May add betablockers when pt. can tolerate” 30 ° Reasons do NOT need to be documented at discharge or otherwise linked to 31 the discharge timeframe: Documentation of reasons anytime during the hospital

32 stay are acceptable (e.g., midhospitalization note stating "no betablockers due http://bmjopen.bmj.com/ 33 to hypotension" select “Yes,” even if documentation indicates that the 34 hypotension had resolved by the time of discharge and the betablocker was 35 restarted). 36 ° Crossing out of a betablocker counts as a "clearly implied reason" for not 37 prescribing a betablocker at discharge only if on a preprinted form. 38  When the current record includes documentation of a prearrival reason for no betablocker, the following countas reasons for no betablocker, regardless of whether 39 this documentation is included in a prearrival record made part of the current record 40 or is noted by hospital staff during the current hospital stay: on September 29, 2021 by guest. Protected copyright. 41  Prearrival betablocker allergy 42  Prearrival hold/discontinuation or notation such as "No betablockers" 43 IF the underlying reason/problem is also noted (e.g., "Atenolol 44 discontinued in transferring hospital secondary to hypotension"). 45  Prearrival "other reason" (other than a hold/discontinuation or notation 46 of "No betablockers") (e.g., "Hx severe hypotension with Lopressor" in 47 transferring ED record). 48  Clarification regarding contraindications specific to evidencebased beta blockers: 49  It is extremely unlikely that all three evidenced beta blockers would not be 50 tolerated in a patient, but a nonevidencebased beta blocker would be 51 tolerated. This scenario is so rare that there is not a need to separate contraindications by beta blocker class (evidencebased and 52 nonevidencebased). 53  In the extremely rare instance all three evidencebased beta blockers are 54 contraindicated in the patient, you can select “Yes”, if the contraindication is 55 documented by a physician and expressly references all three beta blocker 56 medications (e.g. “No Bisprolol, Coreg or Toprol XL all not tolerated”) or 57 58 59 56 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 82 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 specifically states that as a class, “evidencebased beta blockers” are 4 contraindicated (e.g. “evidencebased beta blockers all tried previously, 5 patient is intolerant to all”). This should almost never occur.  Cost is NOT an acceptable reason for not prescribing an evidencebased 6 beta blocker at hospital discharge. 7  Heart Failure patients with reduced EF may come into the hospital on 8 nonevidencebased beta blocker therapy that is well tolerated. This is NOT 9 an acceptable reason for not prescribing an evidencebased beta blocker at 10 discharge. The positive findings in the three evidencebased beta blockers 11 are not indicative of a beta blocker class effect and are specific to these 12 three medications. 13  Suggested Data Sources: 14 Discharge notes 15 ECG reports 16 Excluded Data Sources: Any documentation dated/timed after discharge, Forexcept discharge peer summary review and operative/procedure/diagnostic only test reports 17 (from procedures done during hospital stay) 18 19 Guidelines for Abstraction: 20 21 Inclusion Exclusion 22 2nd/3rd degree heart blocks (HB) Note: The following inclusive Betablocker allergy 23 terms may stand alone or be modified by "variable" or  betablocker allergy described using the negative 24 "intermittent" modifiers or qualifiers 25  Atrioventricular (AV) block described as 2:1, 3:1, 2nd/3rd degree heart blocks (HB) 26 seconddegree, or thirddegree  2nd/3rd degree heart blocks (HB), or any of the 27  Atrioventicular (AV) dissociation other 2nd/3rd degree heart block inclusion terms, 28  Heart block (HB) described as 2:1, 3:1, complete described using the negative modifiers or qualifiers 29 (CHB), high degree, high grade, seconddegree, or  Atrial flutter 30 thirddegree  Atrioventricular (AV) block or conduction block, 31  Heart block, type/degree not specified type/degree not specified  Mobitz Type 1 or 2  Firstdegree atrioventricular (AV) block

32 http://bmjopen.bmj.com/  Wenckebach  Firstdegree heart block (HB) 33 Pacemaker findings  Heart block, type/degree not specified 34  Paced rhythm  Intraventricular conduction delay (IVCD) 35  Paced spikes 36  Pacing described as atrial, AV, dual chamber, or ventricular 37 Discharge records, Progress notes 38 Source of definition: GWTGHF 39

40 on September 29, 2021 by guest. Protected copyright. REQUIRED: Contraindications or Other Documented Reason(s) for Not Providing Beta Blockers 41 42 43 Select all options that apply as to why the patient was not provided Beta Blockers: 44  Asthma 45  Hypotension 46  Allergy 47  Bradycardia (heart rate less than 60 bpm) on day of discharge or day prior to 48 discharge while not on a betablocker 49  Second or thirddegree heart block on ECG on arrival or during hospital stay and 50 does not have a pacemaker 51  Patient recently treated with an intravenous positive inotropic agent 52 Discharge records, Progress notes 53 Source of definition: China PEACE 54 55 56 57 58 59 57 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 83 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 REQUIRED: Aldosterone Antagonist Prescribed at discharge 4 5 Documentation that aldosterone antagonist was prescribed at discharge. 6 7  Yes: An aldosterone antagonist was prescribed at discharge. 8  No: An aldosterone antagonist was not prescribed at discharge OR this information 9 cannot be determined from the medical record. 10 If Yes, (Specify) 11 12 13 REQUIRED: Medication 14 15 16 Select from theFor list the specificpeer aldosterone review antagonist that was only prescribed. 17 18 OPTIONAL: Aldosterone Antagonist: Dosage, Frequency 19 20 Enter the dosage and frequency (optional). Frequency options include: 21 22  Every day 23  2 times a day 24  3 times a day 25  4 times a day 26 Discharge records, Physician orders 27 Source of definition: GWTGHF 28 29 REQUIRED: Aldosterone Antagonist Contraindicated at discharge? 30 31 Documentation of reasons for not prescribing aldosterone antagonist at discharge. 32 http://bmjopen.bmj.com/ 33  Yes: There is a documented contraindication to or reason against aldosterone 34 antagonist prescription at discharge. 35  No: There is no documented contraindication to or reason against aldosterone 36 antagonist prescription at discharge, OR this information cannot be determined from 37 the medical record. 38 39 Notes for Abstraction:

40 on September 29, 2021 by guest. Protected copyright.  Reasons for not prescribing an aldosterone antagonist at discharge must be 41 documented by a physician. 42  Reasons for no aldosterone antagonist must be explicitly documented (e.g., “SCr 43 2.6 mg/dL – No aldosterone antagonist”) or clearly implied (e.g., “Severe 44 hyperkalemia with aldosterone antagonist in past,” "no aldosterone – patient 45 noncompliant with labs," “aldosterone antagonist contraindicated,” “Pt. refusing all 46 medications,” “Supportive care only – no medications,” “aldosterone antagonist 47 therapy not indicated,” aldosterone antagonist on preprinted order form is crossed 48 out, “No aldosterone antagonist” [reason not given]). If reasons are not mentioned in 49 the context of aldosterone antagonist, do not make inferences (e.g., Do not assume 50 that an aldosterone antagonist is not prescribed because of the patient's chronic renal disease alone). 51 ° Crossing out of an aldosterone antagonist counts as a “clearly implied reason" 52 for not prescribing aldosterone antagonist at discharge only if on a preprinted 53 form. 54  Physician documentation of a hold on an aldosterone antagonist or discontinuation 55 of an aldosterone antagonist that occurs during the hospital stay constitutes a “clearly 56 implied” reason for not prescribing an aldosterone antagonist at discharge. A 57 58 59 58 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 84 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 hold/discontinuation of all p.o. medications counts if an aldosterone antagonist p.o. 4 was on order at the time of the notation. 5 ° If there is documentation of a plan to initiate/restart an aldosterone antagonist, and the reason/problem underlying the delay in starting/restarting the 6 aldosterone antagonist is also noted, this constitutes a “clearly implied” reason 7 for not prescribing an aldosterone antagonist at discharge. 8 ° Documentation of a conditional hold/discontinuation of a aldosterone antagonist 9 does not count as a reason for not prescribing a aldosterone antagonist at 10 discharge 11 ° Deferral of an aldosterone antagonist from one physician to another does NOT 12 count as a reason for not prescribing an aldosterone antagonist at discharge 13 unless the problem underlying the deferral is also noted. 14  Documented reasons referring to a more general medication class is not 15 acceptable 16  ReasonsFor do NOT peer need to be documentedreview at discharge only or otherwise linked to the 17 discharge timeframe. Documentation of reasons anytime during the hospital stay is acceptable. 18  An aldosterone antagonist “allergy” or “sensitivity” documented at any time during 19 the hospital stay counts as an allergy regardless of what type of reaction might be 20 noted (e.g., “Allergies: aldosterone antagonist – select “Yes”). 21  Documentation of an allergy/sensitivity to one particular aldosterone antagonist is 22 acceptable to take as an allergy to the entire class of aldosterone antagonist (e.g., 23 "Allergic to Spironolactone "). 24  Aldosterone antagonist (along with ACEI and ARBs) are sometimes described as 25 RAS (reninangiotensin system) or RAAS (reninangiotensinaldosterone system) 26 blockers/inhibitors. Documentation of a reason for not prescribing "RAS" or "RAAS" 27 blockers or inhibitors should be considered implicit documentation of a reason for no 28 aldosterone antagonist at discharge (e.g., "Hold all RAS blockers"). 29  Documentation that refers to a more general medication class, such as "avoid all nephrotoxic medications" or "Hold BP Meds" is not acceptable as a reason for not 30 prescribing aldosterone antagonist at discharge. Documented reasons must mention 31 aldosterone antagonist as a class or a specific aldosterone antagonist medication.

32 http://bmjopen.bmj.com/ Discharge records, Progress notes 33 34 Source of definition: GWTGHF 35 REQUIRED: Contraindications or Other Documented Reason(s) for not Providing Aldosterone 36 37 Antagonist 38 39 Select all that apply as to why the patient was not provided aldosterone antagonist. 40 on September 29, 2021 by guest. Protected copyright. 41  Allergy due to aldosterone receptor antagonist: There is an allergy listed due to 42 the aldosterone receptor antagonist. 43  Hyperkalemia: Hyperkalemia is listed as a contraindication to aldosterone receptor 44 antagonist. 45  Renal dysfunction: defined as creatinine >2.5 mg/dL in men or >2.0 mg/dL in 46 women. 47  Combination of an ACEI and ARB 48 49 Notes for Abstraction: 50 ° Reasons for not prescribing an aldosterone antagonist at discharge must be 51 documented by a physician. 52 ° Reasons for no aldosterone antagonist must be explicitly documented (e.g., 53 “SCr 2.6 mg/dL – No aldosterone antagonist”) or clearly implied (e.g., “Severe 54 hyperkalemia with aldosterone antagonist in past,” “aldosterone antagonist 55 contraindicated,” “Pt. refusing all medications,” “Supportive care only – no 56 medications,” “aldosterone antagonist therapy not indicated,” aldosterone 57 58 59 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 85 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 antagonist on preprinted order form is crossed out, “No aldosterone antagonist” 4 [reason not given]). If reasons are not mentioned in the context of aldosterone 5 antagonist, do not make inferences (e.g., Do not assume that an aldosterone antagonist is not prescribed because of the patient's chronic renal disease 6 alone). 7 Discharge records, Progress notes 8 9 Source of definition: China PEACE and GWTGHF 10 REQUIRED: Anticoagulation Therapy Prescribed at Discharge 11 12 13 Documentation that anticoagulation therapy was prescribed at discharge. 14 15  Select YES if Anticoagulation Therapy was prescribed at discharge 16  Select NO if Anticoagulation Therapy was not prescribed at discharge, OR if this informationFor cannot peer be determined review from the medical record only documentation 17 18 REQUIRED: If yes, Anticoagulation Therapy Was Prescribed at Discharge: 19 20 21 If anticoagulation therapy was prescribed at discharge select the types of medication: 22  Warfarin 23  Direct Thrombin Inhibitor 24  Factor Xa inhibitor 25  Other 26 Discharge records, Physician orders 27 28 Source of definition: GWTGHF 29 30 OPTIONAL: Anticoagulation Medication: Dosage and Frequency 31

32 Select the specific Anticoagulation Medication that was prescribed at discharge. Enter the http://bmjopen.bmj.com/ 33 dosage and frequency (optional). Frequency abbreviations include: 34 35  QD: every day  BID: twice a day 36  TID: 3 times a day 37  QID: 4 times a day 38 39 Discharge records, Physician orders Source of definition: GWTGHF 40 on September 29, 2021 by guest. Protected copyright. 41 42 REQUIRED: Anticoagulation Therapy Contraindicated at Discharge? 43 44 Documentation of a contraindication to Anticoagulation Therapy at discharge. 45 46  Select Yes if there is contraindications to Anticoagulation Therapy at time of 47 discharge. 48  Select No if there are no contraindications to Anticoagulation Therapy at time of discharge. 49 50 Notes for Abstraction: 51 52 Unless a contraindication exists, anticoagulation should be maintained in all patients with 53 heart failure and a history of atrial fibrillation, regardless of whether sinus rhythm is achieved, 54 due to the high rate of silent recurrence of atrial fibrillation with its attendant embolic risk. 55 Even among patients who have undergone catheter ablation therapy or surgical MAZE, there 56 is uncertainty over the longterm risk of AF recurrence. AF can recur without symptoms and 57 58 59 60 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 86 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 without recognition by the patient or physician. Therefore anticoagulation is still indicated in 4 HF patients with catheter ablation therapy or surgical MAZE for AF. 5  Reasons for not prescribing anticoagulation therapy must be documented by a 6 physician, advance practice nurse or physician assistant. 7  If reasons are not mentioned in the context of anticoagulation therapy, do not make 8 inferences (e.g., do not assume that anticoagulation therapy was not prescribed 9 because of a bleeding disorder unless documentation explicitly states so). 10 ° Reasons must be explicitly documented (e.g., “Active GI bleed – 11 anticoagulation therapy contraindicated”, “No warfarin” [no reason given].). 12 ° Physician documentation of a hold on an anticoagulant medication or 13 discontinuation of an anticoagulant medication that occurs during the hospital stay constitutes a “clearly implied” reason for not prescribing anticoagulation 14 therapy at discharge. A hold/discontinuation of all p.o. medications counts if an 15 oral anticoagulant medication (e.g., warfarin) was on order at the time of the 16 Fornotation. peer review only 17 EXCEPTION: 18 19  Documentation of a conditional hold or discontinuation of an anticoagulant 20 medication (e.g., “Hold Coumadin if guaiac positive”, “Stop warfarin if rash persists.”). 21 22  Deferral of anticoagulation therapy from one physician to another does NOT count 23 as a reason for not prescribing anticoagulation therapy at discharge unless the 24 problem underlying the deferral is also noted. Examples: An allergy or adverse 25 reaction to one type of anticoagulant would NOT be a reason for not administering all 26 anticoagulants. Another medication can be ordered. 27 ° “Consulting neurologist to evaluate pt. for warfarin therapy.” select “No”. ° “Rule out GI bleed. Start Coumadin if OK with neurology.” select "Yes”. 28  If there is documentation of a plan to initiate/restart anticoagulation therapy, and 29 the reason/problem underlying the delay in starting/restarting anticoagulation therapy 30 is also noted, this constitutes a “clearly implied” reason for not prescribing 31 anticoagulation therapy at discharge.

32  Acceptable examples (select “Yes”): http://bmjopen.bmj.com/ 33 ° “Stool Occult Blood positive. May start Coumadin as outpatient.” 34 ° “Start warfarin if hematuria subsides.” 35  Unacceptable examples (select “No”): 36 ° “Consider starting Coumadin in a.m.” 37 ° “May add warfarin when pt. can tolerate” 38  Reasons do NOT need to be documented at discharge or otherwise linked to the 39 discharge timeframe: Documentation of reasons anytime during the hospital stay are

40 acceptable (e.g., midhospitalization note stating “no warfarin due to rectal bleeding” on September 29, 2021 by guest. Protected copyright. 41 select “Yes,” even if documentation indicates that the rectal bleeding has resolved by 42 the time of discharge and warfarin was restarted). 43  Crossing out of an anticoagulant medication counts as a "clearly implied reason" for not prescribing anticoagulation therapy at discharge only if on a preprinted form. 44  An allergy or adverse reaction to one type of anticoagulant would NOT be a reason 45 for not administering all anticoagulants. Another medication can be ordered. When the 46 current record includes documentation of a prearrival reason for no anticoagulation 47 therapy, the following counts regardless of whether this documentation is included in a 48 prearrival record made part of the current record or whether it is noted by hospital 49 staff during the current hospital stay: Reasons for not PRESCRIBING anticoagulation 50 therapy at hospital discharge: 51  Prearrival hold/discontinuation or notation such as "No Coumadin" IF the 52 underlying reason/problem is also noted (e.g., “Coumadin held in transferring hospital 53 due to possible GI bleed”) 54 ° Prearrival "other reason" (other than hold/discontinuation or notation of "No 55 warfarin") (e.g., "Hx GI bleeding with warfarin" in transferring ED record). ° Unrepaired intracranial aneurysm 56 ° Other documented by physician 57 58 59 61 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 87 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3  Reasons for not PRESCRIBING anticoagulation therapy at hospital discharge: 4 ° Allergy to all anticoagulant medications 5 ° Aortic dissection 6 ° Bleeding disorder 7 ° Brain/CNS cancer 8 ° CVA, hemorrhagic 9 ° Extensive/metastatic CA 10 ° Hemorrhage, any type 11 ° Intracranial surgery/biopsy 12 ° Patient/family refusal ° Peptic ulcer 13 ° Planned surgery within 7 days following discharge 14 ° Risk of bleeding 15 ° Unrepaired intracranial aneurysm 16 ° ForOther documented peer by physician review only 17 18 Discharge records, Progress notes 19 Source of definition: GWTGHF 20 21 OPTIONAL: Contraindications or Other Documented Reason(s) to Anticoagulation Therapy at 22 Discharge 23 24 25 Select all contraindications to Anticoagulation Therapy that apply. 26  Allergy to or complication r/t anticoagulation therapy 27  Risk for bleeding or discontinued due to bleeding 28  Terminal illness/Comfort Measures Only 29 30 Notes for Abstraction: 31

32  Reasons for not prescribing anticoagulation therapy must be documented by a http://bmjopen.bmj.com/ 33 physician, advance practice nurse or physician assistant. 34  If reasons are not mentioned in the context of anticoagulation, do not make 35 inferences (e.g., do not assume that anticoagulation therapy is not being prescribed 36 because of a bleeding disorder unless documentation explicitly states so.) 37  It is not intended that this list of reasons is inclusive of all possible reasons for not prescribing anticoagulation therapy at discharge. Select if any of these were 38 documented as reasons for not prescribing antithrombotic therapy at discharged. 39 Discharge records, Progress notes

40 on September 29, 2021 by guest. Protected copyright. 41 Source of definition: GWTGHF 42 43 OPTIONAL: Aspirin Prescribed at Discharge 44 45 Documentation that aspirin was prescribed at discharge. 46 47  Select YES if aspirin was prescribed at discharge 48  Select NO if aspirin was not prescribed at discharge, OR if this information cannot be determined from the medical record documentation 49 50 Notes for Abstraction: 51 52  In determining whether aspirin was prescribed at discharge, it is not uncommon to 53 see conflicting documentation amongst different medical record sources. For 54 example, the discharge summary may list an aspirin medication that is not included in 55 any of the other discharge medication sources (e.g., discharge orders). All discharge 56 medication documentation available in the chart should be reviewed and taken into 57 58 59 62 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 88 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 account by the abstractor. 4 ° In cases where there is aspirin in one source that is not mentioned in other 5 sources, it should be interpreted as a discharge medication (select "Yes") unless documentation elsewhere in the medical record suggests that it was 6 NOT prescribed at discharge Consider it a discharge medication in the 7 absence of contradictory documentation. 8 ° If documentation is contradictory (e.g., physician noted "d/c aspirin" in the 9 discharge orders, but aspirin is listed in the summary's discharge medication 10 list), or, after careful examination of circumstances, context, timing, etc, 11 documentation raises enough questions, the case should be deemed "unable to 12 determine" (select "No".) 13 ° Consider documentation of a hold on aspirin after discharge in one location and 14 a listing of aspirin as a discharge medication in another location as contradictory 15 ONLY if the timeframe on the hold is not defined (e.g., “Hold ASA”). Examples 16 of a hold with a defined timeframe include “Hold EC ASA x2 days” and “Hold Foraspirin until peer after endoscopy.” review only 17 ° If aspirin is not listed as a discharge medication, and there is only 18 documentation of a plan to delay initiation/restarting of aspirin for a time period 19 after discharge, select "No." 20  Disregard aspirin documented only as recommended medication for discharge 21 (e.g., “Recommend sending patient home on ASA”). Documentation must be more 22 clear in stating that aspirin was actually prescribed at discharge. 23 24 OPTIONAL: Aspirin: Dose/Frequency 25 26 Select the specific ASA Medication that was prescribed at discharge. Enter the dosage and 27 frequency (optional). Frequency abbreviations include: 28  QD: every day 29  BID: twice a day 30  TID: 3 times a day 31  QID: 4 times a day

32 http://bmjopen.bmj.com/ Discharge records, Physician orders 33 34 Source of definition: GWTGHF 35 OPTIONAL: Aspirin Contraindicated at Discharge? 36 37 38 Reasons for not prescribing aspirin at discharge: 39  Aspirin allergy

40 on September 29, 2021 by guest. Protected copyright. 41  Coumadin/warfarin or Pradaxa/dabigatran prescribed at discharge  Other reasons documented by physician 42 Aspirin reduces the tendency of blood to clot by blocking the action of a type of blood cell 43 involved in clotting. Aspirin improves chances of surviving a heart attack and reduces the risk 44 of recurrence in patients who have experienced a heart attack. 45 Allowable Values: 46 47  Y (Yes): There is documentation of a reason for not prescribing aspirin at 48 discharge. 49  N (No): There is no documentation of a reason for not prescribing aspirin at 50 discharge or unable to determine from medical documentation. 51 Notes for Abstraction: 52 53  Aspirin “allergy” or “sensitivity” documented at any time during the hospital stay counts as an allergy regardless of what type of reaction might be noted (e.g., 54 “Allergies: ASA – Upsets stomach” – select “Yes.”). 55  Documentation of an allergy/sensitivity to one particular type of aspirin is 56 acceptable to take as an allergy to the entire class of aspirincontaining medications 57 58 59 63 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 89 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 (e.g., “Allergic to Empirin”). 4  When determining whether Coumadin/warfarin or Pradaxa/dabigatran was 5 prescribed at discharge (i.e., a reason for not prescribing aspirin at discharge): 6 ° Include Coumadin/warfarin or Pradaxa/dabigatran on hold at discharge but there is documentation of a plan to restart it after discharge. E.g., “Resume 7 Coumadin after INR normalizes.” 8 ° If two discharge summaries are included in the medical record, use the one with 9 the latest date/time. If one or both are not dated or timed, and you cannot 10 determine which was done last, use both. This also applies to discharge 11 medication reconciliation forms. Use the dictated date/time over transcribed 12 date/time, file date/time, etc. 13  When conflicting information is documented in a medical record, select “Yes”. 14  When determining whether there is a reason documented by a physician for not 15 prescribing aspirin at discharge, reasons must be explicitly documented (e.g., 16 “ChronicFor hepatitis peer– No ASA”) or clearlyreview implied (e.g., “GIonly bleeding with aspirin in past,” 17 “ASA contraindicated,” “Pt. refusing all medications,” “Supportive care only – no medications," “Aspirin not indicated,” aspirin on preprinted order form is crossed out, 18 “No aspirin” [no reason given]). If reasons are not mentioned in the context of aspirin, 19 do not make inferences (e.g., Do not assume that aspirin is not being prescribed 20 because of the patient's history of PUD alone). 21 ° Physician documentation of a hold on aspirin or discontinuation of aspirin that 22 occurs during the hospital stay constitutes a “clearly implied” reason for not 23 prescribing aspirin at discharge. A hold/discontinuation of all p.o. medications 24 counts, if aspirin p.o. was on order at the time of the notation. 25  EXCEPTIONS: 26  Documentation of a conditional hold or discontinuation of aspirin does 27 not count as a reason for not prescribing aspirin at discharge (e.g., 28 “Hold ASA if positive Occult Blood stool,” “Stop aspirin if blood in urine 29 recurs”).  Discontinuation of a particular aspirin medication documented in 30 combination with the start of a different aspirin medication (i.e., switch 31 in type of aspirin medication) does not count as a reason for not

32 prescribing aspirin at discharge. http://bmjopen.bmj.com/ 33 34 Examples: 35 “Stop aspirtab” and “Start Ecotrin 81 mg po q am” in same physician order 36 “Change ASA to buffered baby ASA” in progress note 37 “Do not continue after discharge” checked for aspirin and “Continue after 38 discharge” checked for Aspirin Low Dose on a physiciansigned discharge 39 medication reconciliation form  Discontinuation of an aspirin medication at a particular dose 40 on September 29, 2021 by guest. Protected copyright. 41 documented in combination with the start of a different dose of that aspirin (i.e., change in dosage) does not count as a reason for not 42 prescribing aspirin at discharge. 43 44 Examples: 45 “Stop aspirin 325 mg po q am” and “Start aspirin 81 mg po q am” in same 46 physician order 47 “Increase aspirin 81 mg to 325 mg” in progress note 48 "Do not continue after discharge" checked for aspirin 325 mg and "Continue 49 after discharge" checked for aspirin 81 mg on a physiciansigned discharge 50 medication reconciliation form 51  Documented reasons referring to a more general medication class is not acceptable (e.g., “Hold all anticoagulants”). Exception: 52  Documentation of a reason for not prescribing “antiplatelets” should 53 be considered implicit documentation of a reason for no aspirin at 54 discharge (e.g. “Antiplatelet therapy contraindicated”). 55  Deferral of aspirin from one physician to another does NOT count as a 56 reason for not prescribing aspirin at discharge unless the problem 57 58 59 64 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 90 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 underlying the deferral is also noted. 4 5 Examples: 6  “Consulting cardiologist to evaluate pt. for ASA.” select “No.”  “Rule out intracranial bleed. Start ASA if OK with neurology.” select 7 "Yes." 8 9  If there is documentation of a plan to initiate/restart aspirin, and the reason/problem 10 underlying the delay in starting/restarting aspirin is also noted, this constitutes a 11 “clearly implied” reason for not prescribing aspirin at discharge. 12 13 Acceptable examples (select “Yes”):  “Stool Occult Blood positive. May start Bayer EC as outpatient.” 14  “Add buffered aspirin if hematuria subsides” 15 16 UnacceptableFor examples peer (select review “No”): only 17  “Consider starting Ecotrin in a.m.” 18  “May add ASA when pt. can tolerate” 19  Reasons do NOT need to be documented at discharge or otherwise linked to the 20 discharge timeframe: Documentation of reasons anytime during the hospital stay are 21 acceptable (e.g., midhospitalization note stating “no aspirin due to rectal bleeding” 22 select “Yes,” even if documentation indicates that the rectal bleeding has resolved by 23 the time of discharge and aspirin was restarted.) 24  Crossing out of aspirin counts as a "clearly implied reason" for not prescribing 25 aspirin at discharge only if on a preprinted form. 26 27  When the current record includes documentation of a prearrival reason for no 28 aspirin, the following counts regardless of whether this documentation is included in a 29 prearrival record made part of the current record or it is noted by hospital staff during the current hospital stay: 30  Prearrival aspirin allergy 31

32  Prearrival hold/discontinuation or notation such as "No aspirin" IF the underlying http://bmjopen.bmj.com/ 33 reason/problem is also noted (e.g., “ASA held in transferring hospital due to possible 34 GI bleed”). 35  Prearrival "other reason" (other than hold/discontinuation or notation of "No 36 aspirin") (e.g., "Hx GI bleeding with aspirin" in transferring ED record). 37 38 Discharge records, Progress notes 39 Source of definition: GWTGHF

40 on September 29, 2021 by guest. Protected copyright. 41 OPTIONAL: Clopidogrel Prescribed at Discharge 42 43 Documentation that Clopidogrel was prescribed at discharge. 44  Select YES if Clopidogrel was prescribed at discharge 45  Select NO if Clopidogrel was not prescribed at discharge, OR if this information 46 cannot be determined from the medical record documentation 47 48 OPTIONAL: Clopidogrel: Dose/Frequency 49 50 51 Enter the dosage and frequency (optional). Frequency abbreviations include: 52  QD: every day  BID: twice a day 53  TID: 3 times a day 54  QID: 4 times a day 55 56 Discharge records, Physician orders 57 58 59 65 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 91 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 Source of definition: GWTGHF 4 5 OPTIONAL: Other Antiplatelet Prescribed at Discharge 6 7 Documentation that another type of antiplatelet was prescribed at discharge. 8  Yes: Another type of antiplatelet was prescribed at discharge 9  No: Another type of antiplatelet was not prescribed at discharge, OR this 10 information cannot be determined from the medical record documentation 11 12 OPTIONAL: If yes, Medication, Dosage, Frequency (Specify) 13 14 15 Select the specific antiplatelet that was prescribed from the list. 16  Aggrenox (Dipyridamole)  TiclidFor (Ticlopidine) peer review only 17  Prasugrel (Effient) 18  Brilinta (Ticagrelor) 19  Other 20 Enter the dosage and frequency (optional). Frequency abbreviations include: 21  QD: every day 22  BID: 2 times a day 23  TID: 3 times a day 24  QID: 4 times a day 25  Other 26  Unknown 27 Discharge records, Physician orders 28 Source of definition: GWTGHF 29 30 REQUIRED: Hydralazine Nitrate Prescribed at Discharge 31

32 http://bmjopen.bmj.com/ 33 The patient is prescribed both hydralazine and a formulation of nitrates, either as a fixed 34 dose combination or as individual medications. 35  Yes: hydralazine nitrate is prescribed at discharge 36  No: hydralazine nitrate is not prescribed at discharge, OR this information cannot 37 be determined from the medical record. 38 Notes for Abstraction: 39  When hydralazine and nitrate are prescribed as separate medications and not as a

40 on September 29, 2021 by guest. Protected copyright. fixed dose combination, both medications must be administered as routine drugs and 41 should be administered at least 3 times daily. PRN or as needed prescription is not 42 acceptable. Example: Discharge medication prescriptions/instructions: 43 Nitroglycerin sublingual 0.4 mg SL tablet. Dissolve 1 tablet under the tongue as 44 needed for Chest Pain. 45 Hydrazine 25 mg tablet. Take 1 tablet by mouth every 8 hours. 46 Select "No" for Hydralazine Nitrate Prescribed at Discharge. 47  See Appendix, Table 18 for a list of hydralazine and nitrate containing medications. 48  Note: this treatment is recommended in addition to ACEI or ARB and beta blocker 49 therapy at discharge for black heart failure patients with reduced LVEF. 50 Discharge records, Physician orders 51 Source of definition: GWTGHF 52 53 REQUIRED: Contraindication to Hydralazine Nitrate at Discharge 54 55 Contraindications or intolerance to hydralazine and/or nitrates are documented in the 56 medical record. 57 58 59 66 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 92 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3  Yes: There is/are contraindication(s) to hydralazine nitrate at time of discharge. 4  No: There are no contraindications to hydralazine nitrate at time of discharge. 5 Notes for Abstraction: 6 7  Reasons for not prescribing hydralazine nitrate at discharge must be documented by a physician 8  Reasons for no hydralazine nitrate must be explicitly documented or clearly 9 implied. If reasons are not mentioned in the context of hydralazine nitrate, do not make 10 inferences. 11  A hydralazine or nitrate “allergy” or “sensitivity” documented at any time during the 12 hospital stay counts as an allergy regardless of what type of reaction might be noted 13 (e.g., “Allergies: hydralazine or nitrate – select “Yes”). 14  Documentation of an allergy/sensitivity to one particular hydralazine or nitrate 15 medication is acceptable to take as an allergy to the entire class of hydralazine nitrate 16 (e.g., "AllergicFor to Bidil").peer review only 17  Reasons do NOT need to be documented at discharge or otherwise linked to the 18 discharge timeframe. Documentation of reasons anytime during the hospital stay is 19 acceptable.  Physician documentation of a hold on hydralazine nitrate or discontinuation of 20 hydralazine nitrate that occurs during the hospital stay constitutes a “clearly implied” 21 reason for not prescribing hydralazine nitrate at discharge. A hold/discontinuation of 22 all p.o. medications counts if hydralazine nitrate p.o. was on order at the time of the 23 notation. 24 ° If there is documentation of a plan to initiate/restart hydralazine nitrate, and the 25 reason/problem underlying the delay in starting/restarting the hydralazine 26 nitrate is also noted, this constitutes a “clearly implied” reason for not 27 prescribing hydralazine nitrate at discharge. 28 ° Documentation of a conditional hold/discontinuation of hydralazine nitrate does 29 not count as a reason for not prescribing a hydralazine nitrate at discharge. 30 ° Deferral of hydralazine nitrate from one physician to another does NOT count 31 as a reason for not prescribing hydralazine nitrate at discharge unless the problem underlying the deferral is also noted.

32 http://bmjopen.bmj.com/ ° Documented reasons referring to a more general medication class are not 33 acceptable. 34 Discharge records, Progress notes 35 36 Source of definition: GWTGHF 37 38 REQUIRED: Contraindications or Other Documented Reason(s) For Not Providing Hydralazine 39 Nitrate:

40 on September 29, 2021 by guest. Protected copyright. 41 42 Select all contraindications to Anticoagulation Therapy that apply. 43  Symptomatic hypotension 44  Lupus syndrome 45  Allergy 46  Severe renal failure 47 Notes for Abstraction: 48 49  Reasons for not prescribing hydralazine nitrate at discharge must be documented 50 by a physician. 51  Reasons for no hydralazine nitrate must be explicitly documented or clearly 52 implied. If reasons are not mentioned in the context of hydralazine nitrate, do not make 53 inferences. 54 Discharge records, Progress notes 55 Source of definition: GWTGHF 56 57 58 59 67 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 93 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 OPTIONAL: Diabetic Tx at Discharge 4 5 Determine if diabetic medication was prescribed at discharge for patients with a confirmed 6 diagnosis of diabetes (regardless of whether type I or II diabetes mellitus). Hold down the 7 "Ctrl" key on the keyboard to select multiple options or to deselect an option. 8 9  None prescribed/ND: The patient has a confirmed diagnosis of type I or type II diabetes and no diabetic medication including insulin, oral agents or other 10 subcutaneous/injectable agent was prescribed at discharge. 11  None contraindicated: The patient does not a confirmed diagnosis of type I or type 12 II diabetes OR has a documented contraindication to insulin, oral agents and other 13 subcutaneous/injectable agents. 14  Insulin: Insulin was prescribed at discharge 15  Oral agents: oral diabetic medication was prescribed at discharge 16  OtherFor subcutaneous/injectable peer review agents only 17 Discharge records, Physician orders 18 Source of definition: GWTGHF 19 20 OPTIONAL: LipidLowering Medications at Discharge 21 22 23 Enter the cholesterolreducer the patient has been prescribed upon discharge. This field 24 includes absorption inhibitor, niacin, statins, binding resin, fibrates, omega three fatty acids, 25 or other. Select all the lipidlowering medications that apply to the patient. 26 Notes for Abstraction: 27 28  In determining whether cholesterolreducing therapy was prescribed at discharge, 29 it is not uncommon to see conflicting documentation among different medical record 30 sources. For example, the discharge summary may list a drug that is not included in 31 any of the other discharge medication sources (e.g., discharge orders). All discharge medication documentation available in the chart should be reviewed and taken into

32 http://bmjopen.bmj.com/ account by the abstractor. 33  In cases where there is a cholesterolreducing drug noted in one source that is not 34 mentioned in other sources, it should be interpreted as a discharge medication (select 35 “Yes”) unless documentation elsewhere in the medical records suggest that it was 36 NOT prescribed at discharge – Consider it a discharge medication in the absence of 37 contradictory documentation. 38  If documentation is contradictory (e.g., MD noted discontinuation of the 39 cholesterolreducing therapy in the discharge medication orders, but it is listed in the

40 discharge summary’s discharge medication list), or after careful examination of on September 29, 2021 by guest. Protected copyright. 41 circumstances, context, timing, etc., documentation raises enough questions, the case 42 should be deemed “unable to determine” (select “No”). 43  When there is a documented plan to delay initiation/restarting of a cholesterolreducing therapy for a time period after discharge, select “No”. 44 45 OPTIONAL: LipidLowering Medication Classes at Discharge (Specify) 46 47 48 Select the specific lipidlowering class and medication that was prescribed from the list. 49 Enter the dosage and frequency (optional). Frequency abbreviations include: 50  QD: every day 51  BID: twice a day 52  TID: 3 times a day 53  QID: 4 times a day 54 Discharge records, Physician orders 55 Source of definition: GWTGHF 56 57 58 59 68 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 94 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 OPTIONAL: Contraindication to LipidLowering medication at Discharge 4 5  Select Yes if there is contraindications to LipidLowering medications at time of 6 discharge. Contraindications include liver disease. 7  Select No if there is no contraindications to LipidLowering medications at time of 8 discharge. 9 Discharge records, Progress notes 10 Source of definition: GWTGHF 11 12 OPTIONAL: Other Medications at Discharge 13 14 15 Select all other medications prescribed at discharge that apply. The list includes: 16  AntiarrhythmicFor peer review only 17 ° If select antiarrhythmic, then select 18  Amiodarone 19  Dofetilide 20  Sotatol 21  Procainamide 22  Diuretic indicate Loop or Thiazide diuretic 23  Nitrate 24  Renin Inhibitor 25  Ca Channel Blocker: Calcium Channel Blocker 26  Digoxin 27  Ranolazine 28  Other antihypertensive 29  Other 30 Discharge records, Physician orders 31 Source of definition: GWTGHF

32  http://bmjopen.bmj.com/ 33 34 OTHER THERAPIES 35 36 REQUIRED: Documented Indication(s) for Placing or Prescribing ICD Therapy? 37 REQUIRED: ICD Placed or Prescribed? 38 REQUIRED: If No, Documented medical reason(s) for not placing or prescribing ICD therapy? 39 REQUIRED: Documented Indication(s) for Placing or Prescribing CRT Therapy? REQUIRED: CRT Placed or Prescribed? 40 on September 29, 2021 by guest. Protected copyright. 41 REQUIRED: If No, Documented reason(s) for not placing or prescribing CRT therapy at discharge 42 43 REQUIRED: Documented Indication(s) for Placing or Prescribing ICD Therapy? 44 45 Documentation that ICD was medically indicated or other reasons for not placing or 46 prescribing ICD therapy at discharge. 47 ICD is indicated for the following occasions in current Chinese guideline: 48  Primary prevention of SCD to reduce total mortality in selected patients with 49 nonischemic DCM or ischemic heart disease at least 40 days postMI with LVEF≤ 50 35% and NYHA class II or III symptoms on chronic GDMT, who have reasonable 51 expectation of meaningful survival for more than 1 year. 52  Secondary prevention in a patient with a ventricular arrhythmia causing hemodynamic instability, who is expected to survive for >1 year with good functional 53 status, or patient with symptomatic or sustained ventricular arrhythmia (ventricular 54 tachycardia or ventricular fibrillation), reasonable functional status. 55 Discharge records, Progress notes, 56 57 58 59 69 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 95 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 Source of definition: 2014 Chinese guideline for the management of heart failure 4 5 REQUIRED: ICD Placed or Prescribed? 6 7 ICD therapy has been placed prior to or during hospitalization or it is documented in the 8 medical record that ICD placement is planned post hospital discharge. 9 10  Yes: ICD therapy was placed prior to hospitalization, during this hospitalization, or prescribed at time of discharge. 11  No: ICD therapy was not placed or prescribed at time of discharge OR this 12 information cannot be determined from the medical record documentation. 13 Notes for Abstraction: 14 15 ° Physician documentation of “consider ICD placement” is not sufficient to select 16 For"Yes". peer review only 17 Discharge records, Progress notes, Inhospital procedure report 18 Source of definition: GWTGHF 19 20 REQUIRED: If No, Documented medical reason(s) for not placing or prescribing ICD therapy? 21 22 23 Documentation that ICD was not medically indicated or other reasons for not placing or 24 prescribing ICD Documented medical reason(s) for not placing or prescribing ICD therapy at 25 discharge. (Select all that apply.) 26  Contraindications: There is documentation of a contraindication to placing ICD therapy. 27  Not receiving optimal medical therapy: There is documentation in the medical 28 record that the patient has not been taking ACEI or ARB AND beta blocker 29 medications for at least 3 months (unless these medications were contraindicated 30 and/or not tolerated). This would also include physician documentation that ICD 31 therapy was not placed or prescribed due to a change in ACEI, ARB or beta blocker

32 prescription (e.g., “BB dosage increased will evaluate for ICD therapy in 3 months). http://bmjopen.bmj.com/ 33  Any other physician documented reason including not an optimal medical 34 therapy, AMI in prior 40 days, recent revascularization, recent onset of HF: There 35 is documentation in the medical record that the patient had an MI in prior 40 days, 36 recent onset or new diagnosis of HF, recent revascularization (CABG or PTCA within 37 past 90 days), does not have a reasonable expectation for survival with a good functional status for at least one year, or expected survival due to noncardiac illness 38 of less than 12 months or patient is CMO. 39  Patient declined 40 Notes for Abstraction: on September 29, 2021 by guest. Protected copyright. 41 42  Reasons the patient is not eligible for ICD therapy must be documented by a 43 physician. 44  Reasons for no ICD therapy must be explicitly documented or clearly implied and 45 mentioned in the context of ICD therapy, do not make inferences. 46 47 EXCEPTION: In the absence of explicit documentation of reason(s) for not placing or 48 prescribing an ICD (e.g. , “EF = 40% not eligible for ICD” ), documentation in the 49 medical record of any of the following clinical characteristics or conditions that make the patient ineligible for ICD therapy is sufficient to select the specified reason. 50 ° EF>35%, 51 ° new onset HF (newly diagnosed) 52 ° MI in prior 40 days 53 ° Recent revascularization (CABG or PTCA within past 90 days) limited life 54 expectancy (expected survival less than 12 months) 55 ° Patient CMO 56 ° Patient/family refused 57 58 59 70 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 96 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 ° Patient not receiving optimal medical therapy (Optimal medical therapy is 4 defined as taking ACE/ARB and Beta Blocker for at least three months unless 5 these medications were contraindicated and/or not tolerated.) 6 The ACC/AHA heart failure and device guidelines for ICD placement for primary 7 prevention and for CRT device placement recommend that the patient receive 8 recommended, optimal medical therapy for heart failure. Because medical therapy 9 may substantially improve left ventricular ejection fraction (LVEF), consideration of 10 ICD and/or CRT implants should follow documentation of sustained reduction of 11 LVEF despite a course of betablockers and ACE inhibitors or angiotensin receptor 12 blockers (ARBs). For further information on recommended medical therapy for heart 13 failure please see the most current version of the ACC/AHA Heart Failure 14 Guidelines. 15 Progress notes 16 Source of definition:For GWTGHF, peer 2014 Chinesereview guideline for theonly management of heart failure 17 18 REQUIRED: Documented Indication(s) for Placing or Prescribing CRT Therapy? 19 20 Documentation that CRT was not medically indicated or other reasons for not placing or 21 prescribing CRT therapy at discharge. 22 23 CRT is indicated in following occasions in current Chinese guideline: 24  Patients in sinus rhythm with NYHA functional class III and ambulatory class IV 25 heart failure and a persistently reduced ejection fraction, despite optimal 26 pharmacological therapy with a QRS duration of ≥120 ms, LBBB QRS morphology, 27 and an EF ≤35%, who are expected to survive with good functional status for >1 year 28  Patients in sinus rhythm with NYHA functional class II heart failure and a 29 persistently reduced ejection fraction, despite optimal pharmacological therapy with a 30 QRS duration of ≥130 ms, LBBB QRS morphology, and an EF ≤30%, who are 31 expected to survive for >1 year with good functional status Discharge records, Progress notes, Inhospital procedure report 32 http://bmjopen.bmj.com/ 33 Source of definition: 2014 Chinese guideline for the management of heart failure 34 35 REQUIRED: CRT Placed or Prescribed? 36 37 Cardiac resynchronization therapy pacemaker has been place prior to or during 38 hospitalization or it is documented in the medical record that CRT placement is planned post 39 hospital discharge.

40  Yes: CRT therapy was placed prior to hospitalization, during this hospitalization, or on September 29, 2021 by guest. Protected copyright. 41 prescribed at time of discharge. 42  No: CRT therapy was not placed or prescribed at time of discharge OR this 43 information cannot be determined from the medical record documentation. 44 Notes for Abstraction: 45 46  The scheduling to an EP for consideration of CRT is sufficient to select “Yes”. 47  Physician documentation of “consider CRT” is not sufficient to select "Yes". 48 Discharge records, Progress notes 49 Source of definition: GWTGHF 50 51 REQUIRED: If No, Documented reason(s) for not placing or prescribing CRT therapy at 52 discharge 53 54 55 Documentation that CRT was not medically indicated or other reasons for not placing or 56 prescribing CRT therapy at discharge. 57 58 59 71 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 97 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3  Contraindications: There is documentation of a contraindication to placing CRT 4 therapy. 5  Not receiving optimal medical therapy: There is documentation in the medical 6 record that the patient has not been taking ACEI or ARB AND beta blocker medications for at least 3 months (unless these medications were contraindicated 7 and/or not tolerated). This would also include physician documentation that CRT 8 therapy was not placed or prescribed due to a change in ACEI, ARB or beta blocker 9 prescription (e.g., “BB dosage increased will evaluate for CRT therapy in 3 months). 10  Not NYHA functional Class III or ambulatory Class IV 11  Any other physician documented reason including AMI in prior 40 days, 12 recent revascularization, recent onset of HF: There is documentation in the 13 medical record that the patient had an MI in prior 40 days, recent onset or new 14 diagnosis of HF, recent revascularization (CABG or PTCA within past 90 days), does 15 not have a reasonable expectation for survival with a good functional status for at least 16 one year, or expected survival due to noncardiac illness of less than 12 months or patientFor is CMO QRS peer duration <120 review ms. only 17  Patient declined 18 Notes for Abstraction: 19 20  Reasons the patient is not eligible for CRT therapy must be documented by a 21 physician. 22  Reasons for no CRT therapy must be explicitly documented or clearly implied and 23 mentioned in the context of CRT therapy, do not make inferences. 24 25 EXCEPTION: In the absence of explicit documentation of reason(s) for not placing or 26 prescribing CRT Therapy (e.g. , “EF = 40% not eligible for CRT Therapy” ), 27 documentation in the medical record of any of the following clinical characteristics or 28 conditions that make the patient ineligible for CRT therapy is sufficient to select “Yes”. 29 ° patient is NYHA Class I or II, 30 ° patient has QRS duration of < 120 ms EF>35% 31 ° new onset HF (newly diagnosed)

32 http://bmjopen.bmj.com/ ° MI in prior 40 days 33 ° Recent revascularization (CABG or PTCA within past 90 days) limited life 34 expectancy (expected survival less than 12 months) 35 ° Patient CMO 36 ° Patient/family refused 37 ° Patient not receiving optimal medical therapy (Optimal medical therapy is 38 defined as taking ACE/ARB and Beta Blocker for at least three months unless 39 these medications were contraindicated and/or not tolerated.)

40 Progress notes on September 29, 2021 by guest. Protected copyright. 41 Source of definition: GWTGHF, 2014 Chinese guideline for the management of heart failure 42 43 44 45 RISK INTERVENTIONS 46 47 REQUIRED: Smoking Cessation Counseling Given OPTIONAL: Address Activity Level 48 OPTIONAL: Address Symptoms Worsening 49 OPTIONAL: Address Diet (Salt Restricted) 50 OPTIONAL: Address Medications 51 OPTIONAL: Address Weight Monitoring 52 REQUIRED: Follow Up Visit Scheduled 53 54 55 56 57 58 59 72 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 98 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 REQUIRED: Smoking Cessation Counseling Given 4 5 Documentation in the medical record that smoking cessation advice or counseling was given 6 during the hospital stay for patients 18 years of age and older. 7  Select Yes if the patient/caregiver received smoking cessation advice/counseling 8 during hospital stay. 9  Select No if Smoking cessation advice/counseling not given or unable to determine 10 from medical record documentation. 11 12 Notes for Abstraction: 13 14  If the patient refused smoking cessation advice or counseling during this hospital stay, select Yes. 15  If the patient has a history of cigarette smoking within the year prior to the arrival 16 date butFor the patient peer does not currently review smoke, they should only be advised to continue not 17 smoking. For these patients, if this advice/counseling was not done, select No. 18  If the patient is prescribed Wellbutrin (bupropion), it should not be assumed that 19 this is a smoking cessation aid unless specifically noted as such. It is sometimes used 20 as an antidepressant unrelated to smoking. 21  The caregiver is defined as the patient's family or any other person who will be 22 responsible for care of the patient after discharge. 23 Guidelines for Abstraction: 24 25 Inclusion Exclusion 26  Cigarette smoking cessation advice/counseling None 27  Prescription of smoking cessation aid (e.g., Habitrol, NicoDerm, Nicorette, Nicotrol, 28 Prostep, Zyban) during hospital stay or at discharge 29  Prescription of Wellbutrin/bupropion during hospital stay or at discharge aid or 30 alternative FDAapproved smoking cessation medication if prescribed as smoking 31 cessation  Referral to smoking cessation class/program 32 http://bmjopen.bmj.com/ 33  Smoking cessation brochure/handouts/video 34  Direct discussion with patient/caregiver about stopping smoking (e.g., “advised patient to stop smoking”) 35 36 Discharge records, Progress notes 37 Source of definition: GWTGHF 38 39 OPTIONAL: Address Activity Level

40 on September 29, 2021 by guest. Protected copyright. 41 Written discharge instructions or other documentation of educational material given to 42 patient/caregiver addressing the patient's activity level after discharge. 43  Select Yes if discharge instructions/educational material given to patient/caregiver 44 address the patient's activity level after discharge. 45  Select No if discharge instructions/educational material do not address activity, or 46 unable to determine from medical record documentation. 47 48 Notes for Abstraction: 49 50  Acceptable materials include discharge instruction sheets, brochures, booklets, teaching sheets, videos, CDs, and DVDs. 51 ° Documentation must clearly convey that the patient /caregiver was given a copy 52 of the material to take home. When the material is present in the medical record 53 and there is no documentation which clearly suggests that a copy was given, 54 the inference should be made that it was given IF the patient's name or the 55 medical record number appears on the material AND hospital staff or the 56 patient/caregiver has signed the material. 57 58 59 73 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 99 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 ° Use only documentation provided in the medical record itself. Do not 4 review and use outside materials in abstraction. Do not make assumptions 5 about what content may be covered in material documented as given to the patient/caregiver. 6  Written instructions given anytime during the hospital stay are acceptable. 7  If the patient refused written discharge instructions/material which addressed 8 activity, select “Yes.” 9  The caregiver is defined as the patient’s family or any other person (e.g., home 10 health/VNA provider) who will be responsible for care of the patient after discharge. 11 12 Guidelines for Abstraction: 13 14 Inclusion Exclusion 15 Activity Level (Examples) None 16  Activity asFor tolerated peer review only 17  Cardiac rehab 18  Exercise instructions 19  No strenuous activity 20  Physical therapy 21  Regular activity 22  Regular walking 23  Rest 24  Restrict activity 25 Discharge records, Progress notes 26 Source of definition: GWTGHF 27 28 OPTIONAL: Address Symptoms Worsening 29 30 Written discharge instructions or other documentation of educational material given to 31 patient/caregiver addressing what to do if heart failure symptoms worsen after discharge.

32 http://bmjopen.bmj.com/ 33  Select Yes if discharge instructions/educational material given to patient/caregiver 34 address what to do if heart failure symptoms worsen after discharge. 35  Select No if discharge instructions/educational material do not address symptoms OR 36 worsening, unable to determine from medical record documentation. 37 38 Notes for Abstraction: 39  Include instructions/educational material which address what to do if heart failure

40 symptoms recur or do not improve after discharge. Examples: on September 29, 2021 by guest. Protected copyright. 41 ° “Call the hospital if weight gain greater than 2 pounds.” 42 ° “Come to the emergency room if you experience a problem with breathing.” 43 ° “Call physician if edema recurs.” 44 ° “Make an appointment if heart failure symptoms return.” 45  Acceptable materials include discharge instruction sheets, brochures, booklets, 46 teaching sheets, videos, CDs, and DVDs. 47 ° Documentation must clearly convey that the patient /caregiver was given a copy 48 of the material to take home. When the material is present in the medical record 49 and there is no documentation which clearly suggests that a copy was given, the 50 inference should be made that it was given IF the patient's name or the medical 51 record number appears on the material AND hospital staff or the patient/caregiver has signed the material. 52 ° Use only documentation provided in the medical record itself. Do not review 53 and use outside materials in abstraction. Do not make assumptions about what 54 content may be covered in material documented as given to the patient/caregiver. 55  Written instructions given anytime during the hospital stay are acceptable. 56  If the patient refused written discharge instructions/material which addressed 57 58 59 74 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 100 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 worsening heart failure symptoms, select “Yes.” 4  The caregiver is defined as the patient’s family or any other person (e.g., home 5 health/VNA provider) who will be responsible for care of the patient after discharge. 6 Guidelines for Abstraction: 7 8 Inclusion Exclusion 9 Heart failure symptoms  Instructions on heart failure symptoms without mention of what to do if 10  Ankle/foot edema or swelling symptoms worsen 11  Breathing difficulty  Instructions on what to do to do if symptoms worsen, problems occur, the  Decreased exercise tolerance patient's condition changes or worsens, etc., without being specified or 12 described as heart failure in nature (e.g., “Call physician if symptoms get worse,” 13  Edema /swelling (location not “Contact office with any problems.”) specified) 14  Instructions on what to do with worsening symptoms noted only as Not  Fatigue 15 Applicable (N/A), None, or left blank  Shortness of breath (SOB) or other 16  Unchecked checkbox next to instruction (e.g., blank checkbox on discharge breathing difficulty, in anyFor context peerinstruction review sheet next to “Notify only your doctor if you experience swelling in your 17  Weight gain feet.”) 18 Discharge records, Progress notes 19 Source of definition: GWTGHF 20 21 OPTIONAL: Address Diet (Salt Restricted) 22 23 24 Written discharge instructions or other documentation of educational material given to 25 patient/caregiver addressing diet/fluid intake instructions. 26  Select Yes if discharge instructions/educational material given to patient/caregiver 27 address the patient's diet/fluid intake after discharge. 28  Select No if discharge instructions/educational material do not address diet/fluid 29 intake, or unable to determine from medical record documentation. 30 31 Notes for Abstraction:

32 http://bmjopen.bmj.com/ 33  Diet/fluid intake instructions do not need to be specific to heart failure: ANY diet or 34 fluid intake instructions are acceptable. 35  Acceptable materials include discharge instructions sheets, brochures, booklets, teaching sheets, videos, CDs, and DVDs. 36 ° Documentation must clearly convey that the patient /caregiver was given a copy 37 of the material to take home. When the material is present in the medical record 38 and there is no documentation which clearly suggests that a copy was given, 39 the inference should be made that it was given IF the patient's name or the

40 medical record number appears on the material AND hospital staff or the on September 29, 2021 by guest. Protected copyright. 41 patient/caregiver has signed the material. 42 ° Use only documentation provided in the medical record itself. Do not 43 review and use outside materials in abstraction. Do not make assumptions 44 about what content may be covered in material documented as given to the 45 patient/caregiver. 46  Written instructions given anytime during the hospital stay are acceptable. 47  If the patient refused written discharge instructions/material which addressed diet, select “Yes.” 48  The caregiver is defined as the patient’s family or any other person (e.g., home 49 health/VNA provider) who will be responsible for care of the patient after discharge. 50 51 Guidelines for Abstraction: 52 53 Inclusion Exclusion Diet (Examples) None 54  Continue same diet 55  Diet as instructed 56  Diet as tolerated (DAT) 57 58 59 75 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 101 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3  Reg diet 4  Restrict fluids 5  Specific diet (e.g., 2 gm Na+ diet, 1800 ADA 6 diet) noted 7  Tube feedings 8 Discharge records, Progress notes 9 Source of definition: GWTGHF 10 11 OPTIONAL: Address Medications 12 13 Written discharge instructions or other documentation of educational material given to 14 patient/caregiver addressing all discharge medications. Instructions must address at least 15 the names of all discharge medications but may also include other usage instructions such 16 as dosages, Forfrequencies, peer side effects, etc.review only 17 18  Select Yes if discharge instructions/educational material given to patient/caregiver 19 address discharge medications. 20  Select No if discharge instructions/educational material do not address all discharge medications, OR unable to determine from medical record documentation. 21 22 23 Notes for Abstraction: 24 Abstraction is a twostep process: 25 1. Determine all of the medications being prescribed at discharge, based on available 26 medical record documentation. 27  Discharge medication information included in a discharge summary dated 28 after discharge should be used as long as it was added during the hospital’s 29 normal course of completing a medical record per organization policy, or 30 within 30 days after discharge, whichever is sooner.  If discharge medications are noted using only references such as 31 “continue home meds,” “resume other meds,” or “same medications,” rather 32 than lists of the names of the discharge medications, the abstractor should http://bmjopen.bmj.com/ 33 use all sources to compile a list of medications the patient was on prior to 34 arrival (or in the case of acute care transfers, use the medications the patient 35 was on prior to arrival at the first hospital). 36  Disregard all references to laxatives, antacids, vitamins, minerals 37 (EXCEPT potassium), food supplements and herbs, PRN or not, AND 38 disregard references to medications by class only (e.g., “calcium channel 39 blocker”) where the specific medication name is not specified. They are NOT required in the written instructions for the purposes of the Discharge

40 on September 29, 2021 by guest. Protected copyright. Instructions measure (HF1). 41  PRN medications are required on the discharge instructions, with ONE 42 exception: When discharge medications outside of the written discharge 43 instructions are noted using ONLY references such as “continue current 44 medications” or “continue present meds,” rather than lists of the names of the 45 discharge medications, and the abstractor is referencing what medications the 46 patient was taking on the day of discharge (for comparison against the written 47 discharge instructions, to confirm completeness of that list), medications 48 which are clearly listed as PRN (given on an as needed basis only) do NOT 49 need to be included in the instructions. 50  Oxygen should not be considered a medication. 51  Medications which the patient will not be taking at home (and/or the caregiver will not be giving at home) are NOT required in the medication list 52 included in the written discharge instructions (e.g., monthly B12 injections, 53 intermittent IV dobutamine, Natrecor infusions, dialysis meds, chemotherapy). 54 2. Check this list against the written discharge instructions given to the patient 55 to ensure that these instructions addressed at least the names of all of the 56 discharge medications. If a list of discharge medications is not documented 57 58 59 76 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 102 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 elsewhere in the record, and the completeness of the medication list in the 4 instructions cannot be confirmed as complete, or it can be determined to be incomplete, select “No.” 5  EXCEPTION: If a comparison list is not available, and the discharge list in 6 the written discharge instructions cannot be determined to be complete or 7 incomplete, but the written discharge instructions have the name or initials of 8 the physician signed on the form, presume that the list of discharge 9 medications in those instructions is complete. 10  In making medication name comparisons, consider two medications that 11 are brand/trade name vs. generic name or have the same generic 12 equivalent as matches. 13  Examples of matches: 14  Vasotec vs. enalapril 15  Toprol vs. Toprol XL 16 For peer ASA vs.review EC ASA only 17  Prinivil vs. Zestril 18  Lopressor vs. metoprolol 19  Metoprolol vs. metoprolol succinate 20  Examples of mismatches: 21  Lopressor vs. Toprol (metoprolol tartrate vs. metoprolol 22 succinate)  Prevacid vs. Protonix (lansoprazole vs. pantoprazole 23 sodium) 24  If there is documentation that the patient was discharged on insulin(s) of 25 ANY kind, ANY reference to ANY type of insulin in the written discharge 26 instructions is sufficient, for the purposes of the Discharge Instructions 27 measure (HF1). E.g., Dc summary notes patient discharged on “Humulin 28 Insulin” and “Insulin 70/30” is listed on the discharge instruction sheet – 29 Consider this a match. 30 ° In determining the medications prescribed at discharge (step 1 above), all 31 discharge medication documentation available in the chart should be reviewed and taken into account by the abstractor. 32 http://bmjopen.bmj.com/ 33  If there is a medication in one source that is not mentioned in other 34 sources, take it as a discharge medication (i.e., required in the written discharge instructions) unless documentation elsewhere in the medical 35 record suggests that it was NOT prescribed at discharge Consider it a 36 discharge medication in the absence of contradictory documentation. 37  If documentation is contradictory (e.g., physician noted “d/c ASA” or “hold 38 ASA” in the discharge orders, but it is listed in the discharge summary’s 39 discharge medication list), or, after careful examination of circumstances,

40 context, timing, etc., documentation raises enough questions about what on September 29, 2021 by guest. Protected copyright. 41 medications are being prescribed at discharge, the case should be deemed 42 "unable to determine” (select "No”), regardless of whether the medication in 43 question is included in the written discharge instructions. 44  In cases in which there was a therapeutic substitution of a medication (e.g., per hospital formulary Protonix substituted for Prilosec) and it is 45 not clear which medication the patient is being discharged on, select 46 "No” regardless of which medication is included in the written 47 discharge instructions. 48  If there is only documentation of a plan to start/restart a medication after 49 discharge (e.g., “Hold Lasix x 2 days,” “Start Plavix as outpatient”), and it is 50 NOT listed as a discharge medication elsewhere (e.g., “Lasix,” “Plavix”), it is 51 not required in the discharge instructions (but if it is listed on the instructions, 52 this is acceptable). 53  If there is documentation in one location of a plan to start/restart a 54 medication at a defined point after discharge (e.g., “Hold aspirin x 3 days,” 55 “Start aspirin after endoscopy”), AND it is listed as a discharge medication in another location (e.g., “aspirin”), do not regard this as contradictory 56 documentation, and require the medication in the discharge instructions. 57 58 59 77 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 103 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 ° Do not give credit in cases where the patient was given written discharge 4 medication instructions only in the form of written prescriptions. 5 ° Acceptable materials include discharge instruction sheets, brochures, booklets, 6 teaching sheets, videos, CDs, and DVDs. 7  Documentation must clearly convey that the patient/caregiver was given a copy of the material to take home. When the material is present 8 in the medical record and there is no documentation which clearly 9 suggests that a copy was given, the inference should be made that it 10 was given IF the patient's name or the medical record number appears 11 on the material AND hospital staff or the patient/caregiver has signed 12 the material. 13  Use only documentation provided in the medical record itself. 14 Do not review and use outside materials in abstraction. Do not make 15 assumptions about what content may be covered in material 16 Fordocumented peer as given review to the patient/caregiver. only 17  Written instructions given anytime during the hospital stay are acceptable. 18  If the patient refused written discharge instructions/material which addressed discharge medications, select “Yes.” 19  The caregiver is defined as the patient’s family or any other person (e.g., 20 home health/VNA provider) who will be responsible for care of the patient 21 after discharge. 22 23 Guidelines for Abstraction: 24 Inclusion Exclusion 25 26 None Any general reference to a medication regimen (e.g., “continue home meds” listed on 27 discharge instruction sheet), without specific documentation of medication names 28 Discharge records, Progress notes 29 Source of definition: GWTGHF 30 31 OPTIONAL: Address Weight Monitoring

32 http://bmjopen.bmj.com/ 33 34 Written discharge instructions or other documentation of educational material given to 35 patient/caregiver addressing weight monitoring instructions. 36  Select Yes if discharge instructions/educational material given to patient/caregiver 37 address weight monitoring instructions. 38  Select No if discharge instructions/educational material do not address weight 39 monitoring, OR if unable to determine from medical record documentation

40 on September 29, 2021 by guest. Protected copyright. 41 Notes for Abstraction: 42  Acceptable materials include discharge instruction sheets, brochures, booklets, 43 teaching sheets, videos, CDs, and DVDs. 44 ° Documentation must clearly convey that the patient /caregiver was given a copy 45 of the material to take home. When the material is present in the medical record 46 and there is no documentation which clearly suggests that a copy was given, 47 the inference should be made that it was given IF the patient's name or the 48 medical record number appears on the material AND hospital staff or the 49 patient/caregiver has signed the material. 50 ° Use only documentation provided in the medical record itself. Do not 51 review and use outside materials in abstraction. Do not make assumptions 52 about what content may be covered in material documented as given to the 53 patient/caregiver.  Written instructions given anytime during the hospital stay are acceptable. 54  If the patient refused written discharge instructions/material which addressed 55 weight monitoring, select “Yes.” 56  The caregiver is defined as the patient’s family or any other person (e.g., home 57 58 59 78 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 104 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 health/VNA provider) who will be responsible for care of the patient after discharge. 4 Guidelines for Abstraction: 5 6 Inclusion Exclusion 7 Weight monitoring (Examples)  Instructions directed toward weight loss only 8  Call in weights (e.g., “Lose weight” or “report weight loss”) 9  Check weight 10  Contact physician if sudden weight gain 11  Daily weights 12  Watch weight 13  Weigh patient 14  Weigh self 15  Weight check 16 DischargeFor records, Progress peer notes review only 17 Source of definition: GWTGHF 18 19 REQUIRED: Follow Up Visit Scheduled 20 21 22 Was a followup appointment scheduled and documented in the hospitalization medical 23 record? 24  Yes: A followup appointment was scheduled for the patient. 25  No: A followup visit was not scheduled prior, a followup visit was scheduled with a 26 provider for management of condition other than heart failure or cannot be determined 27 from medical record documentation. 28 Notes for Abstraction: 29 30  The followup visit must include the time (a specific day or a given time period after discharge) for a followup hospital visit. 31

32 Discharge records, Progress notes http://bmjopen.bmj.com/ 33 Source of definition: GWTGHF 34 35 36 37 38 39

40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 79 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 105 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 IDEAL CANDIDATES FOR EVALUATING PERFORMANCE MEASURES 4 5 Patients whose lengths of hospital stay exceed 24 hours were included for all the following 6 treatments. 7 8 For angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB), 9 we included patients with ejection fraction (EF) <40%, and without any contraindications for 10 ACEi (allergy to ACEi, hyperkalemia (serum potassium >55 mmol/L), creatinine >2.5 mg/dL 11 in men or >2.0 mg/dL in women, systolic blood pressure <90mmHg, pregnancy, 12 moderatesevere aortic stenosis, or other documented contraindications). 13 14 For betablockers, we included patients with EF <40%, and without any contraindications for 15 betablockers (allergy to betablockers, asthma, second or third degree atrioventricular block 16 with no pacemakerFor implanted, peer systolic blood review pressure <90mmHg, only bradycardia (heart rate <55 17 beats/min) without taking a betablocker, or other documented contraindications). 18 19 For aldosterone antagonist, we included patients with EF <40%, and without any 20 contraindications for aldosterone antagonist (allergy to aldosterone antagonist, hyperkalemia 21 (serum potassium >55 mmol/L), creatinine >2.5 mg/dL in men or >2.0 mg/dL in women, 22 combination of an ACEi and ARB, or other documented contraindications). 23 24 For anticoagulation, we included patients with atrial fibrillation and without any 25 contraindications for anticoagulation (allergy to anticoagulation, history of hemorrhagic stroke 26 or active bleeding) 27 28 For implantable cardioverter defibrillator, we included patients without cancer, and eligible for 29 primary prevention (with guidelinedirected medical therapy, EF ≤35%, NYHA class II or III, 30 and without myocardial infarction in 40 days prior to admission), or secondary prevention 31 (with ventricular tachycardia or ventricular fibrillation).

32 http://bmjopen.bmj.com/ For cardiac resynchronization therapy, we included patients without cancer and with left 33 bundle branch block and guidelinedirected medical therapy, and with either EF ≤35% and 34 QRS duration of ≥120 ms for NYHA class III or IV, or EF ≤30% and QRS duration of ≥130 ms 35 for NYHA class II. 36

37 For evaluation of left ventricular systolic function, we included patients whose lengths of 38 hospital stay exceed 24 hours. 39

40 on September 29, 2021 by guest. Protected copyright. For evaluation of risk intervention at discharge, we included patients whose lengths of 41 hospital stay exceed 24 hours and without transferred out, died or withdrew during 42 hospitalization. 43

44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 80 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 106 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 FULL LIST OF NAME AND PRINCIPAL INVESTIGATORS OF EACH SITE 4 5 Kaifeng Integrative Medicine Hospital, Lei Qin, Jieyun Liu; Haiyan County People's Hospital, 6 Chunhui Xiao, Zhihua Lu; Panyu District, Guangzhou City Central Hospital, Guoqin Chen; 7 Harbin Daoli District People's Hospital, Yongfan Jin; Second Affiliated Hospital of Hebei North 8 University, Wenhui Li; Hohhot, Hohhot Saihan District Second People's Hospital, Rongjuan 9 Zhang; Huzhou Nanxun People's Hospital, Fuqin Zhu; Huangshan Third People's Hospital, 10 Changjie Hong; Jining City People's Hospital, Chuanxin Li; Jiaxing Nanhu District Central 11 Hospital east, Zhihua Sun; Laibin Xingbin Bayi Hospital, Chunhua He; Hongzhou District, 12 Lanzhou City People's Hospital, Ping Zhang; Fuzhou, Jiangxi Province Linchuan People's 13 Hospital, Youzhi Zhan; Qujing Qilin District People's Hospital, Fuyong Li; Qinghai Province 14 Fifth People's Hospital, Hong Wu; Qujiang District People's Hospital, Jianfan Chen; Yuhong 15 District, Shenyang City People's Hospital, Meijuan Piao; Taiyuan Xinghua Ridge Central 16 Hospital, Yue Qu;For Kaiping peer Hospital in Tangshanreview City, Yanmin only Yao; Caidian District, Wuhan 17 City, Hubei Province People's Hospital, Baojun Hou; Xining Third People's Hospital, Qing 18 Feng; Yangling Demonstration Area Hospital, Xiaoqiang Yang; Yichun Second People's 19 Hospital, Ying Yuan; Zhengzhou People's Hospital, Hengliang Liu; Chongqing Sixth People's 20 Hospital, Yonghong Huang; Nanchuan District People's Hospital of Chongqing, Lingxian 21 Zeng; Aba Tibetan and Qiang Autonomous Prefecture People's Hospital, Bo Cai; Alxa 22 League Hospital, Shiguo Hao; Anshan City Double Hill Hospital, Rui Xiao; Anshan Mayor 23 Hospital, Xiang Jin; Baiquan County People's Hospital, Yachen Zhang; Baotou Fourth 24 Hospital, Baohong Zhang; Baoding Second Central Hospital, Guang Ma; Beihua University 25 Hospital, Feng Sun; Peking University People's Hospital, Hong Chen; Peking University 26 Shenzhen Hospital, Chun Wu; Beijing Watson Hospital, Lihua Shang; Beipiao Central 27 Hospital, Han Yu; Bortala Mongol Autonomous Prefecture People's Hospital, Ping Chen; 28 Changtu County First Hospital, Mingbao Sun; Chongren County People's Hospital, Chun 29 Yuan; Zhongshan Hospital Affiliated to Dalian University, Qin Yu; Dalian Central Hospital, 30 Yongchao Zhi; Dashiqiao Central Hospital, Juan Huang; Daofu County People's Hospital in 31 Sichuan Province, Jiekang Liu; Dingyuan County General Hospital, Xinming Ma; Dongyang City People's Hospital, Liang Lu; Dunhua City Hospital, Fanju Meng; Fenghuang County,

32 http://bmjopen.bmj.com/ Hunan Province People's Hospital, Guangyong Liu; Fengshan County People's Hospital, 33 Wen Long; Fujian Provincial Hospital, Yansong Guo; Fuzhou First Affiliated Hospital of Fujian 34 Medical University, Yan Zhang; Fugu County People's Hospital, Ruijun Hao; Gannan County 35 People's Hospital, Mei Chen; Gongcheng Yao Autonomous County People's Hospital, 36 Mingfang Feng; Gongshan Dulong Nu Autonomous County People's Hospital, Xiaoping Wu; 37 Guyuan Yuanzhou District People's Hospital, Xiaoping Gao; Guangchang County People's 38 Hospital, Xiang Fu; Guiping City People's Hospital, Guang Chen; Guangyuan First People's 39 Hospital, Tianxun Wang; Guiyang Medical College Hospital, Lirong Wu; Guilin People's

40 on September 29, 2021 by guest. Protected copyright. Hospital, Diguang Pan; Harbin two four two hospitals, Jiubin Sun; Second Affiliated Hospital 41 of Harbin Medical University, Bo Yu; Haimen People's Hospital, Jie Wu; Hainan West Central 42 Hospital (Pizhou First People's Hospital), Zhongwei Wu; Hainan Medical College Hospital, 43 Yueqiong Kong; Hellinger County People's Hospital, Yongshuan Wu; Helong City People's 44 Hospital, Yinglin Cui; First Affiliated Hospital of Hebei North University, Fangjiang Li; First 45 Affiliated Hospital of Henan University of Science and Technology, Pingshuan Dong; Henan 46 Provincial People's Hospital, Chuanyu Gao; Heze City Hospital, Wentang Niu; Hegang 47 Mining Group Co., Ltd. General Hospital, Xiaowen Pan; Chenxi County People's Hospital, 48 Xuejin He; County People's Hospital, Shengcheng Zhou; Jianghua Yao Autonomous County 49 People's Hospital, Rongjun Wan; Hunan Provincial People's Hospital Mawangdui Hospital, 50 Zhiyi Rong; Hunan Provincial People's Hospital, Xing Wang; Xupu County People's Hospital, 51 Yangzhou Liang; Yongzhou City, Hunan Province Central Hospital, Bin Liu; Yuanling County 52 People's Hospital, Rong Cai; Huayin City People's Hospital, Aiping Wang; Guang'an 53 Huayang City People's Hospital of Sichuan Province, Zhihong Zhang; Hunchun City Hospital, 54 Lijun Yu; Huizhou City People's Hospital, Yuansheng Shen; Jixi City People's Hospital, Jia 55 Wang; Jize County Hospital, Qiu'e Guo; Ji'an City, Jiangxi Province People's Hospital, 56 Xueqiao Wang; Jilin Province, Jilin Integrative Medicine Hospital, Jianping Shi; Jingyu County 57 58 59 81 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 107 of 108 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 People's Hospital, Yuhui Lin; Jilin Provincial People's Hospital, Yuming Du; First Affiliated 4 Hospital of Jiamusi University, Zhaofa He; Jiangxi Provincial People's Hospital, Qing Huang; 5 Jinning County People's Hospital, Lihua Gu; Jingzhou Central Hospital, Jin Xie; Jingxing 6 Hospital, Zhenhai Zhao; Jingxi County People's Hospital, Wen Liang; Jiuquan City People's 7 Hospital, Yaofeng Yuan; Kangbao County People's Hospital, Ruiqing Zhao; Keshiketeng 8 Banner Hospital, Li Wang; Lanping Bai Minority Autonomous County People's Hospital, 9 Runxiang He; Yueqing People's Hospital, Xudong Yu; Laoting County Hospital, Keyong 10 Shang; Liaoyang City Central Hospital, Yingying Li; Liaoyuan Second People's Hospital, 11 Aimin Zhang; Liaoyuan City Central Hospital, Fenghua Wu; Lindian County Hospital, 12 Wenzhou Li; Linxiang City People's Hospital, Xiyuan Zhao; Liujiang County People's Hospital, 13 Meifa Wei; Shougang Shuicheng Iron and Steel (Group) Co., Ltd. General Hospital, Min 14 Zhang; Longyan City, Fujian Province First Hospital, Haiming Yi; Luxi County People's 15 Hospital of Jiangxi Province, Feilong Duan; Luchuan County People's Hospital, Min Feng; 16 Luyi County People'sFor Hospital, peer Yuanxun review Xu; Shijiazhuang Cityonly Luan City People's Hospital, 17 Ruigang Zhao; Macheng City People's Hospital, Hongzhuan Cai; Mengcheng County First 18 People's Hospital, Gaofeng Guo; Menglian Dai Lahu Wa Autonomous County People's 19 Hospital, Xiang Li; Biyang County People's Hospital, Weijuan Zhou; Minxian County People's 20 Hospital in Gansu Province, Yuhong Liu; Muli Tibetan Autonomous County People's Hospital, 21 Hui Peng; Nanan Hospital, Duanping Dai; Nanjing First Hospital, Shaoliang Chen; Nantong 22 City Maternal and Child Health Hospital, Song Chen; Nanyang Central Hospital, Shouzhong 23 Yang; Ningwu County People's Hospital, Junhu An; Piao County People's Hospital of Shanxi 24 Province, Jinsong Jiao; Puding County People's Hospital, Wei Jiang; Qinshui County 25 People's Hospital, Hehua Zhang; Qinyang City People's Hospital, Xiaowen Ma; Qinghai Red 26 Cross Hospital, Yanmei Shen; Quzhou City People's Hospital, Xiaoming Tu; Queshan County 27 People's Hospital, Guoyin Fan; Rongjiang County People's Hospital, Fangning Wang; 28 Rudong County People's Hospital, Dongmei Liu; Ruyang County People's Hospital, 29 Chengning Shen; Heze City, Shandong Province Chengwu County People's Hospital, 30 Fengqin Liu; Lucheng People's Hospital of Shanxi Province, Yunke Zhou; Shangluo City 31 Central Hospital, Yazi Yu; Shangqiu Fourth People's Hospital, Jianjun Pan; Shangqiu Long March People's Hospital, Qian Wang; Shanghai Jiao Tong University School of Medicine

32 http://bmjopen.bmj.com/ Ruijin Hospital, Xiaoxiang Yan; Shaoyang County People's Hospital, Kaiyou Wu; Shengsi 33 People's Hospital, Songguo Wang; Huairen County People's Hospital, Ling Tong; Ying 34 County People's Hospital, Wenbing Zhao; Inner Mongolia Siziwangqi People's Hospital, 35 Hongtu Zhang; Sunan Yugur Autonomous County People's Hospital, Zhansheng Ba; Tianjin 36 Jinghai County Hospital, Yuling Zhang; Tianjin Medical University General Hospital, Yuemin 37 Sun; Tongliao City Horqin District First People's Hospital, Junping Fang; Tongchuan Mines 38 Central Hospital, Guojiong Jia; Tongliang County People's Hospital, Guofu Li; Wencheng 39 County People's Hospital of Zhejiang Province, Junlu Wang; Wuhai People's Hospital,

40 on September 29, 2021 by guest. Protected copyright. Zhaohai Zhou; Wulateqianqi People's Hospital, Jinlan Xu; Wulanchabu City Central Hospital, 41 Dajun Liu; Wuchuan City People's Hospital, Yuanming Yi; Wuqiang County People's Hospital, 42 Binglu Liu; Wuyishan City, Fujian Province Hospital, Qingfei Lin; Xi'an First Hospital, Yuqiang 43 Ji; Xiangtan County People's Hospital, Xiaoshan Yang; Gyantse People's Hospital, Ouzhu 44 Danzeng; Xinmi City First People's Hospital, Jie Dou; Xinshao County People's Hospital, 45 Jintang Wang; Xinghai County People's Hospital, Guohui Zhou; Xingshan County People's 46 Hospital in Hubei Province, Shubing Wu; Xing County, Shanxi Province People's Hospital, 47 Aiping Lv; Xiuwu County People's Hospital, Jianbao Chang; Xuanhan County People's 48 Hospital, Xuan Ma; Yanqing District Hospital in Beijing, Li Yang; Yanggao County People's 49 Hospital, Zhiru Peng; Yitong County People's Hospital of Jilin Province, Haifeng Wang; 50 Yongxing County People's Hospital, Shengyong Deng; Yuyao City, Zhejiang Province 51 People's Hospital, Lian Chen; Yunlong County People's Hospital, Jianxun Yang; Yuncheng 52 City, Shanxi Province Central Hospital, Bo Wang; Zaduo County People's Hospital of Qinghai 53 Province, Cairen Nima; Zhangjiachuan Hui Autonomous County People's Hospital, Shitang 54 Gao; Changjiang Shipping General Hospital, Xiuqi Li; Taizhou Hospital in Zhejiang Province, 55 Yafei Mi; Zhijiang City People's Hospital, Bing Zhang; Fuling Central Hospital in Chongqing, 56 Liquan Xiang; Zhouning County Hospital, Banghua He; Zhuoni County People's Hospital, 57 58 59 82 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 108 of 108 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 Hong Li; Zhuozi County People's Hospital, Julong Hao; Fourth People's Hospital of Zigong 4 City, Yong Yi; Zuo Yun County People's Hospital of Shanxi Province, Ru Duan 5 6 7 8 9 10 11 12 13 14 15 16 For peer review only 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39

40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 83 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from

The China Patient-centered Evaluative Assessment of Cardiac Events (China PEACE) Retrospective Heart Failure Study Design

ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2017-020918.R1

Article Type: Protocol

Date Submitted by the Author: 01-Feb-2018

Campus Bookstore http://bmjopen.bmj.com/ Krumholz, Harlan; Yale University School of Medicine; Yale University School of Public Health Li, Jing; Cardiovascular Institute & Fu Wai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, China Oxford Centre for International Health Research

Primary Subject Cardiovascular medicine Heading: on September 29, 2021 by guest. Protected copyright. Secondary Subject Heading: Evidence based practice, Epidemiology, Research methods

Heart failure < CARDIOLOGY, quality of care, outcomes, Cardiac Keywords: Epidemiology < CARDIOLOGY, China

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 26 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 The China Patient-centered Evaluative Assessment of Cardiac Events (China PEACE) 5 6 Retrospective Heart Failure Study Design 7 8 9 Yuan Yu1, Hongzhao Zhang1, Xi Li1, Yuan Lu2, Frederick A Masoudi3, Harlan M. Krumholz2,4,5, 10 Jing Li1* 11

32 Medicine, Yale University School of Medicine, New Haven, Connecticut, United States. http://bmjopen.bmj.com/ 33

40 on September 29, 2021 by guest. Protected copyright. 41 42 Key words: heart failure, quality of care, outcomes, epidemiology, China 43 44 Word count: 2,955 (main manuscript text excluding title page, abstract, acknowledgments, 45 46 contributor statement, competing interests statement, funding statement, ethical approval 47 statement, transparency statement, data sharing statement, references, figures, and tables) 48 49 50 51 52 53 54 55 56 57 58 59 1 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 26 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 Abstract 4 5 Introduction: Heart failure (HF) is a leading cause of hospitalization in China, which is 6 7 experiencing a rapid increase in cardiovascular disease prevalence. Yet, little is known about 8 9 10 current burden of disease, quality of care, and treatment outcomes of heart failure in China. 11 12 The objective of this paper is to describe the study methodology, data collection and 13 14 15 abstraction, and progress to date of the China Patientcentered Evaluative Assessment of 16 For peer review only 17 18 Cardiac Events Retrospective Heart Failure study (China PEACE 5rHF). 19 20 Methods and analysis: The China PEACE 5rHF study will examine a nationally 21 22 23 representative sample of more than 10,000 patient records hospitalized for HF in 2015 in 24 25 China. The study is a retrospective cohort study. Patients have been selected using a 2stage 26 27 28 sampling design stratified by economic–geographic regions. We will collect patient 29 30 characteristics, diagnostic testing, treatments and inhospital outcomes, including death and 31

32 http://bmjopen.bmj.com/ 33 complications, and charges of hospitalization. Data quality will be monitored by a central 34 35 coordinating center and will address case ascertainment, data abstraction, and data 36 37 38 management. As of October 2017, we have sampled 15,438 medical records from 189 39

40 on September 29, 2021 by guest. Protected copyright. 41 hospitals, and have received 15,057 (97.5%) of these for data collection, and completed data 42 43 abstraction and quality control on 7,971. 44 45 46 Ethics and dissemination: The Central Ethics Committee at the Chinese National Center 47 48 for Cardiovascular Diseases approved the study. All collaborating hospitals accepted central 49 50 51 ethics approval with the exception of 15, which obtained local approval by internal ethics 52 53 committees. Findings will be disseminated in future peerreviewed papers and will serve as a 54 55 56 foundation for improving the care for HF in China. 57 58 59 2 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 26 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 Trial registration number: NCT02877914. 5 6 7 8 9 10 11 12 13 14 15 16 For peer review only 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39

40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 3 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 26 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 Strengths and limitations of this study 5 6 A nationally representative sample of hospitals was generated and the study will 7 8 generate the largest reported cohort of patients with HF in China 9 10 11 Medical records were centrally abstracted guided by a standardized data dictionary and 12 13 governed by rigorous data quality standards. 14 15 16 Data collectedFor included peer national disease review burden, patient only characteristics, pattern of care, 17 18 inhospital charges, and shortterm patient outcomes, which will provide pivotal 19 20 21 information for policymakers to improve healthcare quality. 22 23 Data collection is limited to information available in medical records and patient 24 25 outcomes are limited to those occurring during hospitalization. 26 27 28 29 30 31

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40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 4 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 5 of 26 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 INTRODUCTION 5 6 Heart failure (HF) is a significant public health challenge around the world, including in 7 8 14 5 9 China , where cardiovascular disease is the leading cause of death. Approximately 4.5 10 11 million Chinese residents have HF in 2003, and approximately 500,000 incident cases occur 12 13 6 14 every year. Given China’s aging population and increasing prevalence of cardiovascular 15 16 diseases, the diseaseFor burden peer of HF will risereview rapidly in the coming only years.7,8 17 18 19 Despite the substantially increasing HF burden in China, little is known about patients 20 21 hospitalized for HF. The most recent data on the national epidemiology of HF in China derives 22 23 24 from a survey performed in 2003.9 While studies from single centers reported the average 25 26 27 age of patients with HF has increased and comorbidities have shifted markedly during the 28 29 past decades,1012 national data on demographic characteristics, precipitating factors, 30 31 comorbidities and echocardiographic characteristics of patients with HF remain unknown. 32 http://bmjopen.bmj.com/ 33 34 Due to their limited scope, existing studies also report different proportions of HF with 35 36 1315 37 preserved ejection fraction (HFpEF) and with mildly reduced ejection fraction (HFmrEF). 38 39 Further, while it is widely known that use of guidelinedirected medication is suboptimal in

40 on September 29, 2021 by guest. Protected copyright. 41 42 patients with HF and reduced EF (HFrEF),16,17 none studies have considered patients’ 43 44 indications in identifying candidates for therapies, and few have considered contraindications 45 46 47 to therapy in calculating treatment rates. Furthermore, comparisons in HF care and its 48 49 50 association with outcomes remain unclear across regions in China with different economic 51 52 conditions and medical resources. Globally, substantial regional variations have been 53

54 1821 55 documented in the presentation, underlying causes, management, and outcomes of HF, 56 57 58 59 5 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 6 of 26 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 but the disparities in HF care between China and other countries have not been fully 5 6 elucidated due to a lack of standardized definitions for variables in domestic studies which 7 8 9 could be used for crosscountry comparison. Moreover, validated risk models for Chinese 10 11 patients with HF do not currently exist and the national economic burden for HF has not been 12 13 14 accurately estimated. 15 16 To addressFor these knowledgepeer gaps, review we use the foundation only established by the China 17 18 19 PEACE (Patientcentered Evaluative Assessment of Cardiac Events) platform,2224 to conduct 20 21 China PEACE 5 Retrospective Study of Patients with Heart Failure (China PEACE 5rHF 22 23 24 study), and generate knowledge from a nationally representative sample of patients 25 26 27 hospitalized primarily for HF. The study is descriptive. Rather than testing a specific 28 29 hypothesis, it seeks to characterize the care and associated patient outcomes of HF, thus 30 31 providing a foundation for future quality improvement and research. The specific aims of the 32 http://bmjopen.bmj.com/ 33 34 study are to (1) estimate the national rate and number of hospital admissions for HF; (2) 35 36 37 describe the demographic and clinical characteristics, echocardiographic findings, patterns of 38 39 inhospital care, and inhospital outcomes of patients primarily hospitalized for HF; (3)

40 on September 29, 2021 by guest. Protected copyright. 41 42 examine adherence to guideline recommendations in HF care, including use of 43 44 evidencebased medicine and devices, and evaluation of left ventricular function; (4) 45 46 47 compare treatment patterns across geographiceconomic regions and hospitals, and 48 49 50 determine the association between treatment patterns by setting and patient outcomes; (5) 51 52 compare differences in patient characteristics, treatment approaches, and outcomes between 53 54 55 China and other countries; (6) develop and test prognostic scores to stratify risk; (7) evaluate 56 57 58 59 6 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 7 of 26 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 national charges of HF inhospital care. 5 6 This paper describes the study methodology, data collection and abstraction, and 7 8 9 progress to date of the China PEACE 5rHF Study. The study findings will identify 10 11 opportunities for quality improvement and guide the development of strategies and tools to 12 13 14 improve outcomes for HF in China. 15 16 For peer review only 17 18 19 METHODS 20 21 Design Overview 22 23 24 The China PEACE 5rHF study is a retrospective cohort study that will include a nationally 25 26 27 representative sample of more than 10,000 patients hospitalizations for HF from January 1st, 28 29 2015 to December 31st, 2015 in China, to study patient characteristics, treatment patterns, 30 31 and outcomes nationally and within regions of different socioeconomic development. 32 http://bmjopen.bmj.com/ 33 34 Candidates for inclusion were those at least 18 years old, with a principal discharge diagnosis 35 36 37 of HF, either of newonset or a decompensation of chronic HF regardless of etiology. 38 39 Discharge diagnoses were identified using International Classification of Diseases Clinical

40 on September 29, 2021 by guest. Protected copyright. 41 42 Modification codes 10 (I50.xx, I11.0x, I13.0x or I13.2x), or through discharge diagnosis terms 43 44 if ICD10 codes were unavailable. 45 46 47 The Central Ethics Committee at the Chinese National Center for Cardiovascular 48 49 50 Diseases (NCCD) approved the study. All collaborating hospitals accepted central ethics 51 52 approval with the exception of 15 hospitals, which obtained local approval by internal ethics 53 54 55 committees. The study is registered at www.clinicaltrials.gov (NCT02877914). 56 57 58 59 7 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 8 of 26 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 The Chinese government, which provided financial support for the study in response 5 6 to a grant application, had no role in the design or conduct of the study; in the collection, 7 8 9 management, analysis, and interpretation of the data; or in the preparation or approval of the 10 11 article. 12 13 14 15 16 Sampling DesignFor peer review only 17 18 19 We used a sampling design similar to that used in the China PEACERetrospective 20 21 Study of Acute Myocardial Infarction (AMI).22 We generated a nationally representative 22 23 24 sample of hospitalizations for HF during 2015 using 2stage random sampling. In the first 25 26 27 stage, we identified study hospitals in 5 strata: Easternrural, Centralrural, Westernrural, 28 29 Easternurban, and Central/Westernurban regions to reflect diverse setting of economic 30 31 development and healthcare resources in China. The sampling framework of hospitals 32 http://bmjopen.bmj.com/ 33 34 consisted of those with the capacity to provide inhospital care for HF. In each of the rural 35 36 37 areas (i.e. a county), inhospital care for HF is mainly provided in the central hospital, which is 38 39 the largest general hospital with the greatest clinical capacity in the county to treat severe

40 on September 29, 2021 by guest. Protected copyright. 41 42 acute illness. In the 287 urban areas, inhospital care for HF is mainly undertaken by the 43 44 regionally highestlevel hospitals (usually tertiary hospitals), though both secondary and 45 46 47 tertiary hospitals have the capacity to provide the care. 48 49 50 We sampled hospitals according to the hospital list in 2010 in China, which included 51 52 5,339 secondary and 1,284 tertiary hospitals. In the 3 rural strata, the sampling framework 53 54 55 consisted of the central hospital in each of the predefined rural areas. In the 2 urban strata, 56 57 58 59 8 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 9 of 26 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 the sampling framework consisted of both the tertiary and secondary hospitals in each of the 5 6 predefined urban areas, with military hospitals, prison hospitals, specialized hospitals without 7 8 9 a cardiovascular division, and traditional Chinese medicine hospitals excluded. 10 11 In the second stage, we obtained the database of inpatients for HF from each 12 13 14 hospital, and identified cases using a systematic random sampling procedure. In each of the 15 16 5 regional strata,For we determined peer the sample review size required toonly achieve 2% precision for 17 18 19 describing the primary outcome of inhospital death, which was estimated from other studies 20 21 to be 5%.14,25 To achieve a precision of 2% with an α of 0.05 in each of the 2 urban strata, 22 23 24 assuming an interclass correlation of 0.02 and design effect of 2.6, we would need to sample 25 26 27 2377 medical records among hospitals with an average cluster size of 80. Analogously, to 28 29 achieve a precision of 2% with an α of 0.05 in each of the 3 rural strata, assuming an 30 31 interclass correlation of 0.02 and design effect of 2.2, we would need to sample 2011 medical 32 http://bmjopen.bmj.com/ 33 34 records among hospitals with an average cluster size of 60. Assuming a participation rate of 35 36 37 85% among selected hospitals, we approached 35 hospitals for participation in each stratum 38 39 for a total of 175 hospitals (70 urban and 105 rural). We additionally sampled 15 secondary

40 on September 29, 2021 by guest. Protected copyright. 41 42 hospitals to each of the urban strata, to ensure that diverse hospitals providing care for HF 43 44 were included. Consequently, the total expected sample size was 10800 HF patients across 45 46 47 205 hospitals. 48 49 50 51 52 Data Collection 53 54 55 We trained site investigators to identify all hospitalizations for HF in 2015 from their 56 57 58 59 9 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 10 of 26 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 respective local hospital databases. After we sampled cases at each hospital, we assigned 5 6 each case a unique study ID. Site investigators scanned complete hospital medical charts of 7 8 9 all sampled patients, with direct identifiers concealed (name, national ID, and contact 10 11 information). All documents of a single patient are collated in one folder with a unique and 12 13 14 anonymous Participant ID. To facilitate and improve the quality of scanning process, the 15 16 coordinating centerFor developed peer a software review to manage the scan, only and provided each study site 17 18 19 with a highspeed scanner. All parts of the medical record were required for scanning, 20 21 including the face sheet, admission note, daily progress notes, procedure notes, medication 22 23 24 administration record, and diagnostic procedure reports including echocardiograms, 25 26 27 laboratory test results, physician orders, nursing notes, and discharge summary. Following 28 29 receipt of each chart, research staff at the coordinating center checked the hospitalization ID 30 31 and date of hospital admission to verify patient identity. The data were evaluated to ensure 32 http://bmjopen.bmj.com/ 33 34 completeness, quality and concealment of direct identifiers. Incomplete or poorly scanned 35 36 37 charts were rescanned. Research staff from the coordinating center visited 20 sites to assist 38 39 in processing the sampled cases (Figure 1).

40 on September 29, 2021 by guest. Protected copyright. 41 42 We centrally abstracted data from medical records with a standardized data dictionary. 43 44 Per the China PEACERetrospective AMI study methodology,22 98% accuracy of medical 45 46 47 chart abstraction is ensured by rigorous measures. Two contracted vendors abstracted 48 49 50 details of each patients’ hospitalization using their medical charts. One vendor abstracted the 51 52 part of all medical charts that can be abstracted verbatim without need for interpretation (face 53 54 55 sheet, laboratory test results, and physician orders) via double entry by separate abstractors 56 57 58 59 10 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 11 of 26 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 to ensure accuracy. The other vendor abstracted the other part of all medical charts 5 6 (admission record, discharge record, daily record, and procedure reports). To ensure 7 8 9 accuracy of their interpretation, these latter data are abstracted by certified abstractors and 10 11 reviewed by senior abstractors. All abstractors received training and were certified. Inner 12 13 14 quality control was conducted by vendors. In addition, research staff at the coordinating 15 16 center checked Forthe vendors’ peer quality control review reports and compared only randomly selected records 17 18 19 and abstractions for data accuracy. 20 21

22 23 24 Data Management 25 26 27 All data are protected health information and are securely stored in an encrypted 28 29 passwordprotected database at the coordinating center. Systematic data cleaning includes 30 31 the identification of potential outliers in the data distribution, and the exclusion of duplicate 32 http://bmjopen.bmj.com/ 33 34 records by patient and medical record identification numbers. Suspected errors are reviewed 35 36 37 and resolved by data managers. 38 39

40 on September 29, 2021 by guest. Protected copyright. 41 42 Data Elements 43 44 To compile a candidate list of potential data elements, we examined relevant literature 45 46 47 from both English and Chinese studies. Chinaspecific elements (e.g. traditional Chinese 48 49 50 medicines) were included whenever appropriate. We supplemented these elements with 51 52 variables aligned with the American Heart Association Get With The GuidelinesHF 53

54 26 27 55 (GWTGHF) quality improvement program and the 2005 ACC/AHA clinical data standards , 56 57 58 59 11 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 12 of 26 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 which will permit international comparisons (Table 1). Using these data, we have constructed 5 6 quality indicators that reflect both clinical eligibility as well as documented contraindications to 7 8 9 therapies (Table 2). 10 11 12 13 14 Statistical Analyses 15 16 We will reportFor summary peer statistics review for patient characteristics, only use of diagnostic tests, 17 18 19 treatments received, and inhospital outcomes including complications of care across study 20 21 sites. For each aim, we will use standard parametric techniques for observational data, 22 23 24 including t tests, χ2 tests, Wilcoxon ranksum tests, and generalized linear models. Because 25 26 27 patient characteristics, treatments, and outcomes may be correlated within study sites, 28 29 analyses will account for the effect of clustering. To examine and adjust for differences 30 31 between comparison groups, we will use linear, logistic, Cox proportional hazard, and 32 http://bmjopen.bmj.com/ 33 34 Poisson models with a generalized estimating equation approach and hierarchical models to 35 36 37 stratify patients according to their risk of adverse outcomes. We will assess the relationship of 38 39 candidate variables to inhospital outcomes using appropriate statistical techniques for the

40 on September 29, 2021 by guest. Protected copyright. 41 42 dependent variables. We will further refine the list of candidate variables based on their 43 44 clinical relevance. For those with missing values, we will use statistical method to impute or 45 46 47 discard the variables depending on the percentage of missing. Alternatively, we may stratify 48 49 50 based on the availability of the data. 51 52 53 54 55 Progress to Date 56 57 58 59 12 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 13 of 26 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 Among the sampled 205 hospitals, 11 hospitals did not provide inpatient care for HF 5 6 or have no admissions for HF in 2015. By the end of October 2017, we have obtained lists of 7 8 9 patients hospitalized for HF in 2015 from 189 hospitals (Figure 2), which included 171,167 10 11 hospitalizations. Of these, we sampled 15,438 hospitalizations for the China PEACE 5rHF 12 13 14 study, and acquired medical records of 15,057 (97.5%). 14,592 (96.9%) Medical records 15 16 contained all expectedFor sections. peer For 152 review (80%) of the participating only hospitals, hospital 17 18 19 charges were available to be abstracted from the front page of medical records. For the 20 21 remaining 37 hospitals, we asked local investigators to provide hospital charges for sampled 22 23 24 admission from the financial department of local hospitals, and 11 of them have completed. 25 26 27 28 29 DISCUSSION 30 31 The China PEACE 5rHF study is the first study of HF using rigorous sampling design to 32 http://bmjopen.bmj.com/ 33 34 generate a nationally representative sample of patients and hospitals providing HF care in 35 36 37 China. This study will generate the largest report of patients with HF in China and will 38 39 characterize the national disease burden, patient characteristics, pattern of care, inhospital

40 on September 29, 2021 by guest. Protected copyright. 41 42 charges, and shortterm patient outcomes, which are all fundamental to public health 43 44 policymaking and care quality improvement. The China PEACE 5rHF study is based on the 45 46 47 wellestablished China PEACE research platform, which integrates resources from the 48 49 50 Chinese government, a diverse hospital network, and an international research team to 51 52 translate knowledge of the clinical epidemiology of cardiovascular disease into action for the 53 54 55 benefit of patients. The China PEACE 5rHF study will also take the advantage of China 56 57 58 59 13 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 14 of 26 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 PEACE platform significantly elevating the data quality with techniques regularly employed by 5 6 international clinical trials such as integrated central and onsite monitoring as well as source 7 8 9 document verification. This project also elicits the active participation of hospitals across 10 11 China to ensure that study results are disseminated broadly for the purpose of quality 12 13 14 improvement. 15 16 The ChinaFor PEACE peer5rHF study willreview characterize the onlycurrent HF burden in China, 17 18 19 supporting national estimates of annual hospitalizations for the first time. HF hospitalizations 20 21 bring a significant strain on healthcare systems and national health expenditures all around 22 23 24 the world. The resources dedicated to the hospital care of HF hospitalization in China remain 25 26 27 unclear. This study will have the capacity to estimate charges at the national, regional, 28 29 hospital, and patient levels. These results will inform resource allocation to achieve an 30 31 economical equity and efficiency balance. 32 http://bmjopen.bmj.com/ 33 34 This study will generate evidence to inform contemporary HF medical practice and 35 36 37 improve outcomes. Investigating quality measures for HF care may reveal gaps between 38 39 current clinical guidelines and practice in the realworld, therefore highlighting the need for

40 on September 29, 2021 by guest. Protected copyright. 41 42 future qualityimprovement efforts to ensure that all patients receiving appropriate treatment. 43 44 We anticipate substantial regional and hospital variation in a broad range of institutions. 45 46 47 These findings will indicate opportunities for improvement that are concentrated in some 48 49 50 regions, hospitals and patient groups, and identify opportunities to enhance access to 51 52 medical resource and equity, and improve the quality and value of care. Geographic 53 54 55 variations in clinical characteristics and care of patients hospitalized with HF between China 56 57 58 59 14 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 15 of 26 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 and other countries will have important implications for global clinical trials and outcome 5 6 studies in HF. Risk models derived and validated in domestic patients with HF will help 7 8 9 clinicians guide care and researchers conduct observational studies in the future. All these 10 11 findings may influence policy pertinent to HF care in China, as well as offer important lessons 12 13 14 for other low and middleincome countries. 15 16 The ChinaFor PEACE peer5rHF study hasreview some notable strengths only in its design. It contains 17 18 19 the largest and the only representative sample of hospitalizations for HF in China and 20 21 therefore includes patients from diverse geographic regions and institutions with widely 22 23 24 varied capacities. Information will be available on topics that have not been well studied (e.g. 25 26 27 the use of ICD or CRT in patients with HF). International comparisons will also be possible 28 29 given the alignment of key data elements with the GWTGHF and 2005 ACC/AHA clinical 30 31 data standards. Finally, further targeted examination of additional data elements not included 32 http://bmjopen.bmj.com/ 33 34 in the initial case report forms can be performed as novel questions arise, as the NCCD will 35 36 37 maintain a physical copy of all charts after the initial abstraction. 38 39 This study is further distinguished by its use of data quality control strategies, which

40 on September 29, 2021 by guest. Protected copyright. 41 42 are much more common in multinational clinical trials than in large retrospective studies. We 43 44 devoted significant attention to data quality at the stages of case ascertainment, data 45 46 47 abstraction, and data management. For example, research staff rigorously monitored study 48 49 50 sites to identify all hospitalizations for HF from census databases. Staff also ensured that 51 52 medical records for sampled cases were physically found, properly copied, and transmitted in 53 54 55 full whenever possible. In addition, this study provided central training for abstractors and 56 57 58 59 15 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 16 of 26 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 required rigorous standards for both initial certification and recertification. Medical records 5 6 from abstractors who did not meet recertification requirements were reabstracted by a 7 8 9 second reviewer. 10 11 The China PEACE 5rHF study has some limitations. First, study findings are 12 13 14 dependent on the accuracy and completeness of abstracted medical charts. A common 15 16 problem causedFor by this issue peer is underestimation review of comorbidities only or complications due to 17 18 19 missed documentation. However, the record of lab tests, image examinations, medications 20 21 and procedures are very reliable because these records are subjective and linked with 22 23 24 administrative activities, such as fee charge. Moreover, poor documentation of key variables 25 26 27 will be an important target for quality improvement. Second, HF diagnoses were based on 28 29 medical charts and made by local clinicians, potentially resulting in misclassifications, 30 31 because HF remains a challenging clinical diagnosis. However, the principal discharge 32 http://bmjopen.bmj.com/ 33 34 diagnosis of HF has a high positive predictive value compared with other case assessment 35 36 37 strategies. Finally, our study is also restricted to measuring inhospital outcomes, as we are 38 39 unable to link patientlevel data to a national registry of death. However, the long lengths of

40 on September 29, 2021 by guest. Protected copyright. 41 42 stay in Chinese hospitals relative to those in Western countries should permit more robust 43 44 estimates of shortterm complications including death.14,28,29 Moreover, longterm outcomes 45 46 47 and patient experiences will be collected in the recently launched China PEACE 5 48 49 50 Prospective Study of Patients with Heart Failure. 51 52 The China PEACE 5rHF study is the first study on a nationally representative sample 53 54 55 of Chinese HF patients that assesses the characteristics, inhospital care and outcomes 56 57 58 59 16 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 17 of 26 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 across patients, hospitals and regions in China. It provides a platform through which 5 6 government, healthcare providers, and research organizations can translate knowledge of 7 8 9 the clinical epidemiology of HF into improved care for patients in the context of increasing 10 11 burden. 12 13 14 15 16 For peer review only 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

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40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 17 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 18 of 26 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 Figure Legend 5 6 7 8 Figure 1. China PEACE 5rHF study flow chart and associated quality control assurance 9 10 11 strategies. Flow chart should be read from top to bottom. CRF indicates case report form; and 12 13 Q & A, questions and answers. 14 15 16 For peer review only 17 18 Figure 2. Geographic distribution of participating hospitals in the China PEACE 5rHF study. 19 20 21 Of 205 sampled hospitals, 16 were unable or unwilling to participate, and 189 provided cases 22 23 for the China PEACE 5rHF study 24 25

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40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 18 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 19 of 26 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 Table 1. China PEACE 5rHF study data elements 5 6 Category Example Elements 7 8 Patient demographics Age, sex, ethnicity, insurance status, and smoking status 9 10 Myocardial infarction, atrial fibrillation, chronic kidney disease, Medical history 11 diabetes mellitus, and stroke 12 Clinical characteristics at 13 NYHA, heart rate, blood pressure, rales, and edema 14 admission Coronary artery disease, cardiomyopathy, hypertension, valvular 15 Comorbidities 16 For peer heartreview disease, COPD, only anemia, and cancer 17 Arrhythmia, ischemia, respiratory process, Pneumonia, 18 Reasons for exacerbation uncontrolled hypertension, and noncompliancedietary or medicine 19 20 Laboratory values Creatinine, sodium, potassium, hemoglobin, BNP, and troponin 21 Medications Prior to admission, 22 ACEI/ARB, βblocker, aldosterone antagonist, diuretics, digoxin, 23 and during hospitalization anticoagulation, and traditional Chinese medicine 24 (including dose) 25 26 Inhospital procedures ICD, CRT, pacemaker, PCI, and LVAD 27 Echocardiogram(LVEF, size of chambers, pulmonary 28 29 Diagnostic procedure results hypertension, valvular stenosis or regurgitation), chest Xray, and 30 ECG 31 Total charge, death, shock, stroke, bleeding, myocardial infarction, Inhospital outcomes 32 length of stay, and ICU/CCU duration http://bmjopen.bmj.com/ 33 Plans at hospital discharge Medications, diet, weight monitoring, and followup visit 34 35 NYHA indicates New York Heart Association; COPD, chronic obstructive pulmonary disease; 36 37 BNP, brain natriuretic peptide; ACEI, angiotensinconverting enzyme inhibitor; ARB, 38 39 angiotensin receptor blocker; ICD, implantable cardioverter defibrillators; CRT, cardiac

45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 19 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 20 of 26 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 Table 2. China PEACE 5rHF study performance measures* 5 6 In-hospital initiation Therapies at discharge 7 8 ACEI/ARB for HFrEF ACEI/ARB for HFrEF 9 10 βblockers for HFrEF βblockers for HFrEF 11 12 Aldosterone antagonist for HFrEF Aldosterone antagonist for HFrEF 13 14 Anticoagulation for atrial fibrillation Risk intervention 15 16 Evaluation of left ventricular systolic For peer review only 17 function 18 19 CRT therapy in eligible patients 20 21 ICD therapy in eligible patients 22 23 ACEI indicates angiotensinconverting enzyme inhibitor; ARB, angiotensin receptor blocker; 24 HFrEF heart failure with reduced ejection fraction; ICD, implantable cardioverter defibrillators; 25 26 CRT, cardiac resynchronization therapy. 27 28 *Performance measures will be calculated for individuals with clinical indications according to 29 30 ACC/AHA guidelines and without documented contraindications. 31

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40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 20 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 21 of 26 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 Acknowledgements 5 6 We appreciate the multiple contributions made by project teams at the China Oxford Center 7 8 for International Health Research and YaleNew Haven Hospital Center for Outcomes 9 10 11 Research and Evaluation in the realms of study design and operations. We appreciate 12 13 Xiaofang Yan, Yueyue Xi, Jiangling Liu, Linda Sun, Yuanyuan Luo and Jiamin Liu for their 14 15 16 contributions to Fordata collection, peer Wuhanbilige review Hundei for his contributionsonly to quality control, 17 18 and Jiali Song, Wenbo Zhang, Weihong Guo and Teng Li for their contributions to data 19 20 21 cleaning. We thank Paul W. Horak, Jessica Gao and Ziyue Gao for help in figure and 22 23 language, respectively. We are grateful for the support provided by the Chinese government. 24 25

26 27 28 Author Contributions 29 30 HMK and JL designed the study and take responsibility for all aspects of it. YY wrote the first 31

40 Sources of Funding on September 29, 2021 by guest. Protected copyright. 41 42 43 This project was supported by the National Key Technology R&D Program (2015BAI12B02 44 45 and 2015BAI12B01) from the Ministry of Science and Technology of China, CAMS Innovation 46 47 Fund for Medical Sciences (CIFMS 2016I2M2004), and the 111 Project (B16005). 48 49 50 51 52 Conflicts of interest 53 54 55 Dr. Krumholz works under contract with the Centers for Medicare & Medicaid Services to 56 57 58 59 21 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 22 of 26 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 develop and maintain performance measures, is chair of a cardiac scientific advisory board 4 5 6 for UnitedHealth, and is the recipient of research grants from Medtronic, Inc. and Johnson & 7 8 Johnson through Yale University. Other coauthors declare no relevant conflicts of interest. 9 10 11 12 13 Ethics approval 14 15 16 The Central EthicsFor Committee peer at the Chinese review National Center only for Cardiovascular Diseases 17 18 approved the study. All collaborating hospitals accepted central ethics approval with the 19 20 21 exception of 15 hospitals, which obtained local approval by internal ethics committees. Trial 22 23 Registration Number: NCT02877914. 24 25

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40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 22 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 23 of 26 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 References 4 5 1. Sakata Y, Shimokawa H. Epidemiology of heart failure in Asia. Circulation Journal. 6 7 2013;77(9):22092217. 8 2. Bleumink GS, Knetsch AM, Sturkenboom MC, et al. Quantifying the heart failure epidemic: 9 prevalence, incidence rate, lifetime risk and prognosis of heart failure The Rotterdam Study. 10 European heart journal. 2004;25(18):16141619. 11 3. Sliwa K, Wilkinson D, Hansen C, et al. Spectrum of heart disease and risk factors in a black 12 13 urban population in South Africa (the Heart of Soweto Study): a cohort study. Lancet (London, 14 England). 2008;371(9616):915922. 15 4. Mozaffarian D, Benjamin EJ, Go AS, et al. Heart Disease and Stroke Statistics2016 Update: A 16 Report FromFor the American peer Heart Association. review Circulation. only2016;133(4):e38360. 17 18 5. He J, Gu D, Wu X, et al. Major causes of death among men and women in China. The New 19 England journal of medicine. 2005;353(11):11241134. 20 6. Hu SS, Kong LZ, editors. Report on cardiovascular diseases in China 2009. National Centre of 21 Cardiovascular diseases Encyclopedia of China Publishing House; 2009. 22 7. Ministry of Health of People's Republic of China. China Public Health Statistical Yearbook 23 24 2016. Beijing: Peking Union Medical College Publishing House; 2016. 25 8. Zeng Y, Wang Z. A Policy Analysis on Challenges and Opportunities of Population/Household 26 Aging in China. Journal of Population Ageing. 2014;7(4):255281. 27 9. Gu DF, Huang GY, Wu XG, et al. Investigation of prevalence and distributing feature of chronic 28 29 heart failure in Chinese adult population. Zhonghua xin xue guan bing za zhi. 2003(01):69. 30 10. Pei ZY, Zhao YS, Li JY, Xue Q, Gao L, Wang SW. Fifteenyear evolving trends of etiology and 31 prognosis in hospitalized patients with heart failure. Zhonghua xin xue guan bing za zhi.

40 on September 29, 2021 by guest. Protected copyright. 41 outcomes of heart failure patients with different left ventricular ejection fractions. Zhonghua nei 42 ke za zhi. 2017;56(4):253257. 43 14. Zhang J, Zhang YH. China Heart Failure Registry Study——A Multicenter, Prospective 44 Investigation for Preliminary Analysis on Etiology, Clinical Features and Treatment in Heart 45 46 Failure Patients. Zhongguo Xun Huan Za Zhi. 2015(05):413416. 47 15. Liu DP, Wang F, Zeng XZ, Zhang XC. Clinical characteristics and prognosis of heart failure 48 with normal left ventricular ejection fraction in elderly patients. Chinese medical journal. 49 2012;125(16):28532857. 50 51 16. Fu R, Xiang J, Bao H, et al. Association between process indicators and inhospital mortality 52 among patients with chronic heart failure in China. European journal of public health. 53 2015;25(3):373378. 54 17. He XY, Bundorf MK, Gu JJ, Zhou P, Xue D. Compliance with clinical pathways for inpatient 55 care in Chinese public hospitals. BMC health services research. 2015;15:459. 56 57 58 59 23 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 24 of 26 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 18. West R, Liang L, Fonarow GC, et al. Characterization of heart failure patients with preserved 4 ejection fraction: a comparison between ADHEREUS registry and ADHEREInternational 5 registry. European journal of heart failure. 2011;13(9):945952. 6 7 19. Lam CS, Teng TK, Tay WT, et al. Regional and ethnic differences among patients with heart 8 failure in Asia: the Asian sudden cardiac death in heart failure registry. European heart journal. 9 2016. 10 20. Callender T, Woodward M, Roth G, et al. Heart failure care in low and middleincome 11 countries: a systematic review and metaanalysis. PLoS medicine. 2014;11(8):e1001699. 12 13 21. Dokainish H, Teo K, Zhu J, et al. Global mortality variations in patients with heart failure: 14 results from the International Congestive Heart Failure (INTERCHF) prospective cohort study. 15 The Lancet. Global health. 2017. 16 22. DharmarajanFor K, Li peer J, Li X, Lin Z,review Krumholz HM, Jiang only L. The China PatientCentered 17 18 Evaluative Assessment of Cardiac Events (China PEACE) Retrospective Study of Acute 19 Myocardial Infarction: Study Design. Circ Cardiovasc Qual Outcomes. 2013;6(6):732740. 20 23. Li J, Li X, Wang Q, et al. STsegment elevation myocardial infarction in China from 2001 to 21 2011 (the China PEACERetrospective Acute Myocardial Infarction Study): a retrospective 22 analysis of hospital data. Lancet (London, England). 2015;385(9966):441451. 23 24 24. Kirtane AJ, Stone GW. STEMI care in China: a world opportunity. Lancet (London, England). 25 2015;385(9966):400401. 26 25. Yin Q, Zhao Y, Li J, et al. The coexistence of multiple cardiovascular diseases is an 27 independent predictor of the 30day mortality of hospitalized patients with congestive heart 28 29 failure: a study in Beijing. Clinical cardiology. 2011;34(7):442446. 30 26. Get With The Guidelines@ Heart failure. 31 http://www.heart.org/HEARTORG/Professional/GetWithTheGuidelines/GetWithTheGuidelines

40 on September 29, 2021 by guest. Protected copyright. 41 International Society for Heart and Lung Transplantation: endorsed by the Heart Failure 42 Society of America. Circulation. 2005;112(12):18881916. 43 28. Kapoor JR, Kapoor R, Ju C, et al. Precipitating Clinical Factors, Heart Failure Characterization, 44 and Outcomes in Patients Hospitalized With Heart Failure With Reduced, Borderline, and 45 46 Preserved Ejection Fraction. JACC. Heart failure. 2016;4(6):464472. 47 29. Filippatos G, Farmakis D, Bistola V, et al. Temporal trends in epidemiology, clinical 48 presentation and management of acute heart failure: results from the Greek cohorts of the 49 Acute Heart Failure Global Registry of Standard Treatment and the European Society of 50 51 CardiologyHeart Failure pilot survey. European heart journal. Acute cardiovascular care. 52 2014. 53 54 55 56 57 58 59 24 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 25 of 26 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 For peer review only 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

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40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 Figure 1. China PEACE 5r-HF study flow chart and associated quality control assurance strategies. Flow chart 46 should be read from top to bottom. CRF indicates case report form; and Q & A, questions and answers. 47 48 128x168mm (600 x 600 DPI) 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 26 of 26 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 For peer review only 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

The China Patient-centered Evaluative Assessment of Cardiac Events (China PEACE) Retrospective Heart Failure Study Design

ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2017-020918.R2

Article Type: Protocol

Date Submitted by the Author: 22-Mar-2018

Campus http://bmjopen.bmj.com/ Krumholz, Harlan; Yale University School of Medicine; Yale University School of Public Health Li, Jing; Cardiovascular Institute & Fu Wai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, China Oxford Centre for International Health Research

Primary Subject Cardiovascular medicine Heading: on September 29, 2021 by guest. Protected copyright. Secondary Subject Heading: Evidence based practice, Epidemiology, Research methods

Heart failure < CARDIOLOGY, quality of care, outcomes, Cardiac Keywords: Epidemiology < CARDIOLOGY, China

15 16 Author Affiliations 1 For peer review only 17 National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of 18 Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, 19 20 Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's 21 Republic of China; 22 2 Center for Outcomes Research and Evaluation, YaleNew Haven Hospital, and Department 23 of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, United 24 25 States; 26 3 Division of Cardiology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, 27 United States; 28 4 Department of Health Policy and Management, Yale School of Public Health, New Haven, 29 30 Connecticut, United States; 31 5 Section of Cardiovascular Medicine, and the Robert Wood Johnson Clinical Scholars

32 Program the Robert Wood Johnson Clinical Scholars Program, Department of Internal http://bmjopen.bmj.com/ 33 34 Medicine, Yale University School of Medicine, New Haven, Connecticut, United States. 35 36 * Corresponding author: Professor Jing Li 37 National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of 38 39 Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, 167

40 BeilishiRoad, Beijing 100037, People’s Republic of China; Tel: +86 10 8839 6077; Email: on September 29, 2021 by guest. Protected copyright. 41 [email protected] 42 43 44 Key words: heart failure, quality of care, outcomes, epidemiology, China 45 46 Word count: 3,042 (main manuscript text excluding title page, abstract, acknowledgments, 47 48 contributor statement, competing interests statement, funding statement, ethical approval 49 statement, transparency statement, data sharing statement, references, figures, and tables) 50 51 52 53 54 55 56 57 58 59 1 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 26 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 Abstract 4 5 Introduction: Heart failure (HF) is a leading cause of hospitalization in China, which is 6 7 experiencing a rapid increase in cardiovascular disease prevalence. Yet, little is known about 8 9 10 current burden of disease, quality of care, and treatment outcomes of heart failure in China. 11 12 The objective of this paper is to describe the study methodology, data collection and 13 14 15 abstraction, and progress to date of the China Patientcentered Evaluative Assessment of 16 For peer review only 17 18 Cardiac Events Retrospective Heart Failure study (China PEACE 5rHF). 19 20 Methods and analysis: The China PEACE 5rHF study will examine a nationally 21 22 23 representative sample of more than 10,000 patient records hospitalized for HF in 2015 in 24 25 China. The study is a retrospective cohort study. Patients have been selected using a 2stage 26 27 28 sampling design stratified by economic–geographic regions. We will collect patient 29 30 characteristics, diagnostic testing, treatments and inhospital outcomes, including death and 31

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40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 3 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 26 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 Strengths and limitations of this study 5 6 A nationally representative sample of hospitals was generated and the study will 7 8 generate the largest reported cohort of patients with HF in China 9 10 11 Medical records were centrally abstracted guided by a standardized data dictionary and 12 13 governed by rigorous data quality standards. 14 15 16 Data collectedFor included peer national disease review burden, patient only characteristics, pattern of care, 17 18 inhospital charges, and shortterm patient outcomes, which will provide pivotal 19 20 21 information for policymakers to improve healthcare quality. 22 23 Data collection is limited to information available in medical records and patient 24 25 outcomes are limited to those occurring during hospitalization. 26 27 28 29 30 31

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54 22 55 Study of Acute Myocardial Infarction (AMI). We generated a nationally representative 56 57 58 59 7 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 8 of 26 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 sample of hospitalizations for HF during 2015 using 2stage random sampling. In the first 5 6 stage, we identified study hospitals in 5 strata: Easternrural, Centralrural, Westernrural, 7 8 9 Easternurban, and Central/Westernurban regions to reflect diverse setting of economic 10 11 development and healthcare resources in China. The sampling framework of hospitals 12 13 14 consisted of those with the capacity to provide inhospital care for HF. In each of the rural 15 16 areas (i.e. a county),For inhospital peer care for reviewHF is mainly provided only in the central hospital, which is 17 18 19 the largest general hospital with the greatest clinical capacity in the county to treat severe 20 21 acute illness. In the 287 urban areas, inhospital care for HF is mainly undertaken by the 22 23 24 regionally highestlevel hospitals (usually tertiary hospitals), though both secondary and 25 26 27 tertiary hospitals have the capacity to provide the care. 28 29 We sampled hospitals according to the hospital list in 2011 in China, which included 30 31 6,623 nonmilitary hospitals. In the 3 rural strata, the sampling framework consisted of the 32 http://bmjopen.bmj.com/ 33 34 central hospital in each of the predefined rural areas. In the 2 urban strata, the sampling 35 36 37 framework consisted of both the tertiary and secondary hospitals in each of the predefined 38 39 urban areas, with prison hospitals, specialized hospitals without a cardiovascular division,

40 on September 29, 2021 by guest. Protected copyright. 41 42 and traditional Chinese medicine hospitals excluded. 43 44 In the second stage, we obtained the database of inpatients for HF from each 45 46 47 hospital, and identified cases using a systematic random sampling procedure. In each of the 48 49 50 5 regional strata, we determined the sample size required to achieve 2% precision for 51 52 describing the primary outcome of inhospital death, which was estimated from other studies 53

54 14,25 55 to be 5%. To achieve a precision of 2% with an α of 0.05 in each of the 2 urban strata, 56 57 58 59 8 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 9 of 26 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 assuming an interclass correlation of 0.02 and design effect of 2.6, we would need to sample 5 6 2377 medical records among hospitals with an average cluster size of 80. Analogously, to 7 8 9 achieve a precision of 2% with an α of 0.05 in each of the 3 rural strata, assuming an 10 11 interclass correlation of 0.02 and design effect of 2.2, we would need to sample 2011 medical 12 13 14 records among hospitals with an average cluster size of 60. Assuming a participation rate of 15 16 85% among selectedFor hospitals, peer we approached review 35 hospitals only for participation in each stratum 17 18 19 for a total of 175 hospitals (70 urban and 105 rural). We additionally sampled 15 secondary 20 21 hospitals to each of the urban strata, to ensure that diverse hospitals providing care for HF 22 23 24 were included. Consequently, the total expected sample size was 10800 HF patients across 25 26 27 205 hospitals. 28 29 30 31 Data Collection 32 http://bmjopen.bmj.com/ 33 34 We trained site investigators to identify all hospitalizations for HF in 2015 from their 35 36 37 respective local hospital databases. After we sampled cases at each hospital, we assigned 38 39 each case a unique study ID. Site investigators scanned complete hospital medical charts of

40 on September 29, 2021 by guest. Protected copyright. 41 42 all sampled patients, with direct identifiers concealed (name, national ID, and contact 43 44 information). All documents of a single patient are collated in one folder with a unique and 45 46 47 anonymous Participant ID. To facilitate and improve the quality of scanning process, the 48 49 50 coordinating center developed a software to manage the scan, and provided each study site 51 52 with a highspeed scanner. All parts of the medical record were required for scanning, 53 54 55 including the face sheet, admission note, daily progress notes, procedure notes, medication 56 57 58 59 9 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 10 of 26 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 administration record, and diagnostic procedure reports including echocardiograms, 5 6 laboratory test results, physician orders, nursing notes, and discharge summary. Following 7 8 9 receipt of each chart, research staff at the coordinating center checked the hospitalization ID 10 11 and date of hospital admission to verify patient identity. The data were evaluated to ensure 12 13 14 completeness, quality and concealment of direct identifiers. Incomplete or poorly scanned 15 16 charts were rescanned.For Research peer staff fromreview the coordinating only center visited 20 sites to assist 17 18 19 in processing the sampled cases (Figure 1). 20 21 We centrally abstracted data from medical records with a standardized data dictionary. 22 23 24 Per the China PEACERetrospective AMI study methodology,22 98% accuracy of medical 25 26 27 chart abstraction is ensured by rigorous measures. Two contracted vendors abstracted 28 29 details of each patients’ hospitalization using their medical charts. One vendor abstracted the 30 31 part of all medical charts that can be abstracted verbatim without need for interpretation (face 32 http://bmjopen.bmj.com/ 33 34 sheet, laboratory test results, and physician orders) via double entry by separate abstractors 35 36 37 to ensure accuracy. The other vendor abstracted the other part of all medical charts 38 39 (admission record, discharge record, daily record, and procedure reports). To ensure

40 on September 29, 2021 by guest. Protected copyright. 41 42 accuracy of their interpretation, these latter data are abstracted by certified abstractors and 43 44 reviewed by senior abstractors. All abstractors received training and were certified. Inner 45 46 47 quality control was conducted by vendors. In addition, research staff at the coordinating 48 49 50 center checked the vendors’ quality control reports and compared randomly selected records 51 52 and abstractions for data accuracy. 53 54 55 56 57 58 59 10 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 11 of 26 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 Data Management 5 6 All data are protected health information and are securely stored in an encrypted 7 8 9 passwordprotected database at the coordinating center. Systematic data cleaning includes 10 11 the identification of potential outliers in the data distribution, and the exclusion of duplicate 12 13 14 records by patient and medical record identification numbers. Suspected errors are reviewed 15 16 and resolved byFor data managers. peer review only 17 18 19 20 21 Data Elements 22 23 24 To compile a candidate list of potential data elements, we examined relevant literature 25 26 27 from both English and Chinese studies. Chinaspecific elements (e.g. traditional Chinese 28 29 medicines) were included whenever appropriate. We supplemented these elements with 30 31 variables aligned with the American Heart Association Get With The GuidelinesHF 32 http://bmjopen.bmj.com/ 33 34 (GWTGHF) quality improvement program26 and the 2005 ACC/AHA clinical data standards27, 35 36 37 which will permit international comparisons (Table 1). Using these data, we have constructed 38 39 quality indicators that reflect both clinical eligibility as well as documented contraindications to

40 on September 29, 2021 by guest. Protected copyright. 41 42 therapies (Table 2). 43 44

45 46 47 Ethics and Dissemination 48 49 50 The Central Ethics Committee at the Chinese National Center for Cardiovascular 51 52 Diseases (NCCD) approved the study. All collaborating hospitals accepted central ethics 53 54 55 approval with the exception of 15 hospitals, which obtained local approval by internal ethics 56 57 58 59 11 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 12 of 26 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 committees. The study is registered at www.clinicaltrials.gov (NCT02877914). 5 6 The Chinese government, which provided financial support for the study in response 7 8 9 to a grant application, had no role in the design or conduct of the study; in the collection, 10 11 management, analysis, and interpretation of the data; or in the preparation or approval of the 12 13 14 article. Findings will be disseminated in future peerreviewed papers and will serve as a 15 16 foundation for improvingFor thepeer care for HF review in China. only 17 18 19 20 21 Patient and Public Involvement 22 23 24 The China PEACE 5rHF study is a retrospective study based on abstraction of 25 26 27 medical records. Patients were not involved in the recruitment or conduct of the study. The 28 29 study findings will not be disseminated directly to patients, although the findings will inform 30 31 quality improvement initiatives in hospitals after the dissemination of the study results. The 32 http://bmjopen.bmj.com/ 33 34 study does not include patient advisors. 35 36 37 38 39 Statistical Analyses

40 on September 29, 2021 by guest. Protected copyright. 41 42 We will report summary statistics for patient characteristics, use of diagnostic tests, 43 44 treatments received, and inhospital outcomes including complications of care across study 45 46 47 sites. For each aim, we will use standard parametric techniques for observational data, 48

49 2 50 including t tests, χ tests, Wilcoxon ranksum tests, and generalized linear models. Because 51 52 patient characteristics, treatments, and outcomes may be correlated within study sites, 53 54 55 analyses will account for the effect of clustering. To examine and adjust for differences 56 57 58 59 12 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 13 of 26 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 between comparison groups, we will use linear, logistic, Cox proportional hazard, and 5 6 Poisson models with a generalized estimating equation approach and hierarchical models to 7 8 9 stratify patients according to their risk of adverse outcomes. We will assess the relationship of 10 11 candidate variables to inhospital outcomes using appropriate statistical techniques for the 12 13 14 dependent variables. We will further refine the list of candidate variables based on their 15 16 clinical relevance.For For those peer with missing review values, we will use only statistical method to impute or 17 18 19 discard the variables depending on the percentage of missing. Alternatively, we may stratify 20 21 based on the availability of the data. 22 23 24 25 26 27 Progress to Date 28 29 Among the sampled 205 hospitals, 11 hospitals did not provide inpatient care for HF 30 31 or have no admissions for HF in 2015. By the end of October 2017, we have obtained lists of 32 http://bmjopen.bmj.com/ 33 34 patients hospitalized for HF in 2015 from 189 hospitals (Figure 2), which included 171,167 35 36 37 hospitalizations. Of these, we sampled 15,438 hospitalizations for the China PEACE 5rHF 38 39 study, and acquired medical records of 15,057 (97.5%). 14,592 (96.9%) Medical records

40 on September 29, 2021 by guest. Protected copyright. 41 42 contained all expected sections. For 152 (80%) of the participating hospitals, hospital 43 44 charges were available to be abstracted from the front page of medical records. For the 45 46 47 remaining 37 hospitals, we asked local investigators to provide hospital charges for sampled 48 49 50 admission from the financial department of local hospitals, and 11 of them have completed. 51 52 53 54 55 DISCUSSION 56 57 58 59 13 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 14 of 26 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 The China PEACE 5rHF study is the first study of HF using rigorous sampling design to 5 6 generate a nationally representative sample of patients and hospitals providing HF care in 7 8 9 China. This study will generate the largest report of patients with HF in China and will 10 11 characterize the national disease burden, patient characteristics, pattern of care, inhospital 12 13 14 charges, and shortterm patient outcomes, which are all fundamental to public health 15 16 policymaking andFor care quality peer improvement. review The China PEACE only 5rHF study is based on the 17 18 19 wellestablished China PEACE research platform, which integrates resources from the 20 21 Chinese government, a diverse hospital network, and an international research team to 22 23 24 translate knowledge of the clinical epidemiology of cardiovascular disease into action for the 25 26 27 benefit of patients. The China PEACE 5rHF study will also take the advantage of China 28 29 PEACE platform significantly elevating the data quality with techniques regularly employed by 30 31 international clinical trials such as integrated central and onsite monitoring as well as source 32 http://bmjopen.bmj.com/ 33 34 document verification. This project also elicits the active participation of hospitals across 35 36 37 China to ensure that study results are disseminated broadly for the purpose of quality 38 39 improvement.

40 on September 29, 2021 by guest. Protected copyright. 41 42 The China PEACE 5rHF study will characterize the current HF burden in China, 43 44 supporting national estimates of annual hospitalizations for the first time. HF hospitalizations 45 46 47 bring a significant strain on healthcare systems and national health expenditures all around 48 49 50 the world. The resources dedicated to the hospital care of HF hospitalization in China remain 51 52 unclear. This study will have the capacity to estimate charges at the national, regional, 53 54 55 hospital, and patient levels. These results will inform resource allocation to achieve an 56 57 58 59 14 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 15 of 26 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 economical equity and efficiency balance. 5 6 This study will generate evidence to inform contemporary HF medical practice and 7 8 9 improve outcomes. Investigating quality measures for HF care may reveal gaps between 10 11 current clinical guidelines and practice in the realworld, therefore highlighting the need for 12 13 14 future qualityimprovement efforts to ensure that all patients receiving appropriate treatment. 15 16 We anticipate substantialFor regionalpeer and hospitalreview variation in aonly broad range of institutions. 17 18 19 These findings will indicate opportunities for improvement that are concentrated in some 20 21 regions, hospitals and patient groups, and identify opportunities to enhance access to 22 23 24 medical resource and equity, and improve the quality and value of care. Geographic 25 26 27 variations in clinical characteristics and care of patients hospitalized with HF between China 28 29 and other countries will have important implications for global clinical trials and outcome 30 31 studies in HF. Risk models derived and validated in domestic patients with HF will help 32 http://bmjopen.bmj.com/ 33 34 clinicians guide care and researchers conduct observational studies in the future. All these 35 36 37 findings may influence policy pertinent to HF care in China, as well as offer important lessons 38 39 for other low and middleincome countries.

40 on September 29, 2021 by guest. Protected copyright. 41 42 The China PEACE 5rHF study has some notable strengths in its design. It contains 43 44 the largest and the only representative sample of hospitalizations for HF in China and 45 46 47 therefore includes patients from diverse geographic regions and institutions with widely 48 49 50 varied capacities. Information will be available on topics that have not been well studied (e.g. 51 52 the use of ICD or CRT in patients with HF). International comparisons will also be possible 53 54 55 given the alignment of key data elements with the GWTGHF and 2005 ACC/AHA clinical 56 57 58 59 15 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 16 of 26 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 data standards. Finally, further targeted examination of additional data elements not included 5 6 in the initial case report forms can be performed as novel questions arise, as the NCCD will 7 8 9 maintain a physical copy of all charts after the initial abstraction. 10 11 This study is further distinguished by its use of data quality control strategies, which 12 13 14 are much more common in multinational clinical trials than in large retrospective studies. We 15 16 devoted significantFor attention peer to data quality review at the stages of caseonly ascertainment, data 17 18 19 abstraction, and data management. For example, research staff rigorously monitored study 20 21 sites to identify all hospitalizations for HF from census databases. Staff also ensured that 22 23 24 medical records for sampled cases were physically found, properly copied, and transmitted in 25 26 27 full whenever possible. In addition, this study provided central training for abstractors and 28 29 required rigorous standards for both initial certification and recertification. Medical records 30 31 from abstractors who did not meet recertification requirements were reabstracted by a 32 http://bmjopen.bmj.com/ 33 34 second reviewer. 35 36 37 The China PEACE 5rHF study has some limitations. First, study findings are 38 39 dependent on the accuracy and completeness of abstracted medical charts. A common

40 on September 29, 2021 by guest. Protected copyright. 41 42 problem caused by this issue is underestimation of comorbidities or complications due to 43 44 missed documentation. However, the record of lab tests, image examinations, medications 45 46 47 and procedures are very reliable because these records are subjective and linked with 48 49 50 administrative activities, such as fee charge. Moreover, poor documentation of key variables 51 52 will be an important target for quality improvement. Second, HF diagnoses were based on 53 54 55 medical charts and made by local clinicians, potentially resulting in misclassifications, 56 57 58 59 16 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 17 of 26 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 4 because HF remains a challenging clinical diagnosis. However, the principal discharge 5 6 diagnosis of HF has a high positive predictive value compared with other case assessment 7 8 9 strategies. Finally, our study is also restricted to measuring inhospital outcomes, as we are 10 11 unable to link patientlevel data to a national registry of death. However, the long lengths of 12 13 14 stay in Chinese hospitals relative to those in Western countries should permit more robust 15 16 estimates of shorttermFor complications peer including review death.14,28,29 onlyMoreover, longterm outcomes 17 18 19 and patient experiences will be collected in the recently launched China PEACE 5 20 21 Prospective Study of Patients with Heart Failure. 22 23 24 The China PEACE 5rHF study is the first study on a nationally representative sample 25 26 27 of Chinese HF patients that assesses the characteristics, inhospital care and outcomes 28 29 across patients, hospitals and regions in China. It provides a platform through which 30 31 government, healthcare providers, and research organizations can translate knowledge of 32 http://bmjopen.bmj.com/ 33 34 the clinical epidemiology of HF into improved care for patients in the context of increasing 35 36 37 burden. 38 39

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26 27 28 Author Contributions 29 30 HMK and JL designed the study and take responsibility for all aspects of it. YY wrote the first 31

40 Sources of Funding on September 29, 2021 by guest. Protected copyright. 41 42 43 This project was supported by the National Key Technology R&D Program (2015BAI12B02 44 45 and 2015BAI12B01) from the Ministry of Science and Technology of China, CAMS Innovation 46 47 Fund for Medical Sciences (CIFMS 2016I2M2004), and the 111 Project (B16005). 48 49 50 51 52 Conflicts of interest 53 54 55 Dr. Krumholz works under contract with the Centers for Medicare & Medicaid Services to 56 57 58 59 21 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 22 of 26 BMJ Open: first published as 10.1136/bmjopen-2017-020918 on 10 May 2018. Downloaded from 1 2 3 develop and maintain performance measures, is chair of a cardiac scientific advisory board 4 5 6 for UnitedHealth, and is the recipient of research grants from Medtronic, Inc. and Johnson & 7 8 Johnson through Yale University. Other coauthors declare no relevant conflicts of interest. 9 10 11 12 13 Ethics approval 14 15 16 The Central EthicsFor Committee peer at the Chinese review National Center only for Cardiovascular Diseases 17 18 approved the study. All collaborating hospitals accepted central ethics approval with the 19 20 21 exception of 15 hospitals, which obtained local approval by internal ethics committees. Trial 22 23 Registration Number: NCT02877914. 24 25

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